After all the talents, the gluttonous event Sofantinib biliary tumor RWS clinical research project kick-off meeting was successfully held!

*Only for medical professionals to read and reference Sofantinib enters the field of biliary tumor research, looking forward to setting off a new chapter in the diagnosis and treatment of biliary tumors! The article was reviewed by Professor Zhang Zongli and Professor Lu Jun.
On September 18, 2021, the "Hutchison Medical Biliary Tract Tumor (RWS)" clinical research project kick-off meeting was grandly held in Jinan, Shandong.
Many hepatobiliary experts gathered together to discuss the biliary tract.
Conduct academic lectures and exchanges on the status and progress of tumor diagnosis and treatment
.

The conference aims to improve the overall level of biliary tract tumor treatment in China, and promote the continuous development of standardized and personalized treatment models and strategies for biliary tract tumors
.

The big names gathered and the talents came to discuss the current status, progress and future directions of the research on biliary tract tumors in my country, and officially launched the real-world research of Sofatinib in the treatment of biliary tract tumors! The on-site conference invited Professor Zhang Zongli from Qilu Hospital of Shandong University and Professor Lu Jun from Shandong Provincial Hospital to jointly serve as the chairmen of the conference and give an opening speech.
The two professors first expressed their gratitude to the attending experts for coming, and both said that Sofatinib is Hutchison Medicine Following Fruquintinib, another innovative small molecule targeted drug developed independently.
It has completed clinical research verification in China and conducted extended clinical research in the United States.
This transnational action allows everyone to see Hutchison Medicine’s Strength
.

As we all know, China is a country with a high incidence of liver and gallbladder tumors.
Due to the hidden incidence, most patients are already advanced patients when they see a doctor
.

The disease progresses rapidly and there is a lack of effective treatment methods.
How to effectively improve the overall survival of patients, improve the survival rate and quality of life is a problem that needs to be solved urgently
.

Everyone is very happy to see the efficacy and safety of Sofantinib in the treatment of biliary tract tumors.
It is another choice in the field of biliary tract tumors
.

I hope that through today’s exchanges, everyone will help each other and make progress together
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Professor Zhang Zongli of Qilu Hospital of Shandong University, Professor Lu Jun of Shandong Provincial Hospital and Ms.
Cui Bin, Director of Huang Medicine’s Marketing Department, introduced the R&D history and company development of Sofantinib.
She said: “Hutchison Medicine is committed to innovation.
A biopharmaceutical company engaged in drug research and development, and its three drugs, fruquintinib, sofatinib , and savotinib, have been approved for marketing
.
In the
future, in the field of biliary tumors, Hutchison Pharmaceuticals has deployed sofatinib as a single drug , And Sofatinib combined with immunotherapy and other clinical research.
In addition, the company also has other biliary tumor products in the process of clinical research
.
It is
hoped that through many explorations, more cancer patients in China will benefit
.

"Ms.
Cui Bin, Marketing Director, Biliary Tumor Targeting and The latest progress in immunity Professor Lu Jun from Shandong Provincial Hospital explained the latest progress in targeting and immunotherapy for biliary tumors
.

Professor Lu Jun said that targeted and immunotherapy in the field of biliary tumors is in the ascendant, and the future application directions are mainly: individualization, precision, and integration
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Among them, the combined application of anti-vascular targeted drugs with immune activation such as sofantinib and immune checkpoint inhibitors is a promising exploration direction in the field of biliary tract, and it is expected to produce a synergistic effect
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At the 2021 American Society of Clinical Oncology (ASCO) conference, the results of a phase II clinical study of sofatinib as a single agent for the second-line treatment of advanced biliary tract tumors were released.
The 16-week progression-free survival rate (PFS%) was 46.
33%, and the median was none.
Progressive survival (mPFS) is 3.
7 months, and median overall survival (mOS) is 6.
9 months [1], showing good efficacy and safety.
This study has been published in Cancer
.

In addition, a multi-center phase II clinical study (NCT04169672) of sofatinib combined with teriprizumab is currently underway to explore the efficacy and safety of sofatinib combined with immunotherapy in the treatment of advanced BTC.
It is expected that more Patients with multiple biliary tract tumors bring better survival benefits
.

Professor Lu Jun of Shandong Provincial Hospital, Professor Du Futian from Weifang People’s Hospital, Professor Tian Hu from the First Affiliated Hospital of Shandong First Medical University, and Professor Cao Jingyu from Qingdao University Affiliated Hospital The experience of treatment and the main points discussed are summarized as follows: For unresectable locally advanced and metastatic biliary tract tumors, the efficacy of standard first-line chemotherapy is limited, and there are unmet clinical needs
.

"Precision therapy" may be the development direction of BTC therapy; based on the BTC immune microenvironment, combined with drugs that target other immune cells, is a potential strategy to improve the efficacy of immune checkpoint inhibitors
.

Research on the treatment of biliary tract tumors with sofatinib combined with teriprizumab, nivolumumab combined with ipilimumab and other combined programs is actively being carried out, and we look forward to the announcement of positive results
.

Observations and assumptions on the current status of the diagnosis and treatment of cholangiocarcinoma, Professor Zhang Zongli from Qilu Hospital of Shandong University expressed his observations and assumptions on the current status of the diagnosis and treatment of cholangiocarcinoma through clinical cases
.

The prognosis of cholangiocarcinoma in China is poor, the precise diagnosis and treatment lacks guidelines, and the level of diagnosis and treatment is uneven.
Basic clinical research is completely behind European and American countries.
The diagnosis and treatment of cholangiocarcinoma is heterogeneous.
Scale cohort study
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Professor Zhang Zongli put forward four ideas: ①Establish a software system for information collection and follow-up of cholangiocarcinoma, and initially explore the model of information-based medical consortium for cholangiocarcinoma
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②Establish a cohort of cholangiocarcinoma with the largest sample size in China
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③Identify a series of prognostic markers of cholangiocarcinoma and study the molecular mechanisms that affect the prognosis
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④Summarize the results in the targeted and immunological clinical treatment of cholangiocarcinoma
.

Professor Zhang Zongli from Qilu Hospital of Shandong University, Professor He Qiang from Linyi City People’s Hospital, Professor Ma Changlin from Jining First People’s Hospital, and Professor Guo Xingjun from Dongying City People’s Hospital had a wonderful discussion.
The main points of the discussion are summarized as follows: Through the establishment of a cholangiocarcinoma clinical research center And demonstration bases to improve the level of diagnosis and treatment of cholangiocarcinoma in China, and improve the level of clinical and basic research on cholangiocarcinoma
.

Shandong Province has established the largest cholangiocarcinoma cohort and specimen bank with complete specimens and follow-up systems that have been reported in the province
.

By constructing a tissue chip for the cholangiocarcinoma cohort, clinical verification and transformation can be quickly completed
.

Bile duct neuroendocrine tumor treatment case discussion Professor Qian Ruikun from Jining First People's Hospital shared a case of bile duct neuroendocrine tumor
.

Neuroendocrine tumors originate from cells derived from the diffuse neuroendocrine system
.

There are reports in the literature that for extrahepatic bile duct neuroendocrine tumors, surgery is the only cure, radical resection is performed as soon as possible, and the 5-year survival rate can reach 67%
.

The enhanced MR of the upper abdomen of this patient suggested the common hepatic duct-upper common bile duct occupying space, which is considered to be cholangiocarcinoma
.

On March 17, 2021, the patient was pathologically diagnosed as mixed neuroendocrine-non-neuroendocrine tumor after laparoscopic radical resection of hilar cholangiocarcinoma under general anesthesia
.

The patient received a combination therapy of sofatinib + sintilimab + cisplatin + etoposide after surgery
.

On August 30, re-examination showed that liver metastases basically disappeared
.

On September 10, the patient discontinued the drug due to adverse reactions such as oral ulcers, bleeding gums, and bone marrow suppression
.

Professor Qian Ruikun from the First People’s Hospital of Jining City, Professor Zhou Xu from Shandong Provincial Hospital, Professor Bao Guangjian from Zaozhuang Municipal Hospital, and Professor Gao Yanchao from Liaocheng People’s Hospital discussed the case.
The main points of the discussion are summarized as follows: Sofatinib combined with chemotherapy and Immune checkpoint inhibitors have significant effects
.

What needs attention is that in the follow-up treatment of this patient, one drug can be considered to be subtracted from the four-drug combination plan to reduce the risk of adverse reactions
.

For the remaining liver metastases of this patient, needle biopsy and pathological examination can be performed to guide subsequent clinical decision-making
.

Interpretation of the real-world study of Sofantinib in the treatment of biliary tract tumors Professor Xu Yunfei from Qilu Hospital of Shandong University introduced the real-world research project on the safety and effectiveness of Sofantinib in the treatment of biliary tract tumors.
Professor Xu Yunfei first pointed out that Sofantinib Fully inhibit VEGFR-1/2/3, FGFR-1 and CSF-1R, block tumor angiogenesis, and at the same time promote immune response
.

Previous studies have shown that Sofatinib is safe for the second-line treatment of biliary tract cancer, and the research of Sofantin combined with immunotherapy for biliary tract tumors is being explored
.

The real-world study of sofantinib in the treatment of biliary tract tumors is a prospective, single-arm, open, observational, multi-center clinical study.
The research plan includes 200 cases of unresectable or unresectable or unresectable cases diagnosed by histopathology or cytology Patients who cannot undergo radical surgical resection (patients with positive resection margins are allowed to be included) or patients with metastatic intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma are treated with sofatinib (300 mg QD Q4W) until the patient's disease progresses, death, and toxicity Intolerance or withdrawal of informed consent
.

The study endpoints include: progression-free survival (PFS), objective response rate (ORR), overall survival (OS), disease control rate (DCR) and safety
.

Professor Xu Yunfei from Qilu Hospital of Shandong University had an intense discussion with all the guests.
The main points of the discussion were summarized as follows: Sofatinib combined with PD-1 proved to be effective in a variety of solid tumors, and a phase II study showed that Sofatinib has efficacy in the field of biliary tumors.
Good, safe and good
.

The application of sofatinib combined with immunotherapy in biliary tract tumors is worth looking forward to
.

The subgroup analysis plan of the real-world study of sofatinib in the treatment of biliary tract tumors includes: dosing schedule (different dosing schedules, starting dose), dose adjustment (with or without adjustment), front-line treatment plan (targeted drugs, Chemotherapy, immune combination therapy, etc.
), whether Sofatinib is used across the line (yes, no)
.

Treatment of Sofatinib Adverse Reactions Professor Cao Jingyu from Qingdao University Affiliated Hospital discussed the common adverse reactions of Sofatinib and treatment principles.
Common adverse reactions of Sofatinib ≥ grade 3 include hypertension, proteinuria, hemorrhage and so on
.

The treatment principles are: ①When grade 3 hypertension occurs, if the blood pressure is still over 160/100 mmHg after starting antihypertensive treatment or adjusting the existing antihypertensive treatment, and the blood pressure still exceeds 160/100 mmHg and continues for more than 3 days, the treatment should be suspended; if it returns to 1 within 28 days Level or baseline level, then reduce a dose level
.

The occurrence of grade 4 hypertension requires discontinuation of treatment
.

②When the urine routine examination shows urine protein + or ++, or the 24-hour urine protein quantitative test <2.
0g, maintain the original dose; when the 24-hour urine protein quantitative test ≥2.
0 g, it should be carried out according to the prescribed dosage adjustment principle Adjustment
.

③ When grade 1 bleeding occurs, maintain the original dose level; when grade 2 bleeding occurs, stop the medication, and restore to ≤ grade 1 within 28 days, and reduce the dose level; when grade 3 bleeding occurs, stop the treatment
.

Professor Cao Jingyu from the Affiliated Hospital of Qingdao University, Professor Li Enshan from Linyi Tumor Hospital, Professor Guo Xingjun from Liaocheng People’s Hospital, and Professor Bao Guangjian from Zaozhuang Municipal Hospital had a heated discussion.
The main points of the discussion were summarized as follows: Common adverse reactions of anti-angiogenic drugs include: hypertension, rash or dry, itchy skin, hand-foot skin reaction, diarrhea and fatigue
.

The principles of the whole-process management of anti-angiogenic drug-related adverse reactions include: attention to high-risk factors before treatment, close monitoring during treatment, dose adjustment, and drug withdrawal
.

The drugs that are prohibited or used with caution during the administration of small molecule anti-angiogenic drugs include: anticoagulant or prevent thrombosis drugs, drugs that cause cardiac QT interval prolongation, and drugs that interfere with liver P450 enzymes
.

Summary of the conference: Looking up and down, the extraordinary conference is coming to an end.
The chairmen of the conference, Professor Zhang Zongli and Professor Lu Jun, jointly made summary speeches.
It is hoped that through the convening of this conference, a new chapter in the diagnosis and treatment of biliary tumors will be opened.
The real-world research on the treatment of biliary tract tumors by Nineti has been progressing smoothly, and good results have been passed on frequently.
In order to broaden the exploration of tumor patients, it is extraordinary! Expert Profile Professor Zhang Zongli, Chief Physician, Doctoral Supervisor, Shandong University Qilu Hospital, Director of General Surgery, Shandong University Qilu Hospital Chairman of the Hepatobiliary Surgery Branch of the AssociationDeputy Leader of the Hepatology Group of the General Surgery Branch of the Shandong Medical AssociationDeputy Chairman of the Hepatobiliary and Pancreatic Disease Academic Committee of the Shandong Management Association Chairman of Shandong Anti-Cancer Association Hepatobiliary Tumor Branch Standing Committee Member of the "Journal of Laparoscopic Surgery", "Advances in Modern General Surgery in China" and other journals University professor, doctoral supervisor, well-known expert of Shandong Provincial Hospital, Director of Hepatobiliary Surgery, Eastern Hospital of Shandong Provincial Hospital, Member of the Standing Committee of the International Hepatobiliary and Pancreatic Association Chinese Branch of the Biliary Tract Professional Committee, International Hepatobiliary and Pancreatic Association Chinese Branch, Hepatobiliary and Pancreatic MDT Committee Standing Committee, International Hepatobiliary and Pancreatic Association Chinese Branch Member of the ERAS Professional Committee of Hepatobiliary and Pancreatic Surgery Member of the Retroperitoneal Oncology Group of the Oncology Branch of the Chinese Medical Association Director, Hepatobiliary and Pancreatic Surgery Professional Committee of Shandong Geriatrics Association Chairperson, Cross-Strait Medical and Health Exchange Association, Oncology Prevention Professional Committee Member, China Laparoscopic Liver Resection Development and Improvement Professional Committee Member, China Research Hospital Association Digital Medicine Clinical Surgery Professional Committee Standing Committee Member, China Research Member of the Liver Cancer Group of the Hepatobiliary and Pancreatic Surgery Professional Committee of the Chinese Medical Doctor Association Member of the Pancreatic Neuroendocrine Tumor Committee of the Pancreatic Disease Committee of the Chinese Medical Doctor Association References: [1] YX Bai, Journal of Clinical Oncology 2021 39: 15_suppl, e16123-e16123.
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