biliary tract carcinoma
Conditions
Interventions
experimental:S-1 combined with Camrelizumab and Apatinib
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 18-70 years old, male or female; 2. Primary cholangiocarcinoma (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma), gallbladder cancer, unresectable locally advanced or advanced cholangiocarcinoma and gallbladder cancer confirmed by imaging histology; 3. Patients who have progressed on first-line PD-L1 inhibitor therapy (single agent or combination); 4. The best efficacy of first-line immunotherapy is CR, PR or SD, and the first-line treatment of PFS = 3 months; 5. First-line PD-L1 therapy did not cause grade 3-4 immune-related adverse reactions to lead to discontinuation; 6. Have a measurable lesion that meets RECIST v1.1 criteria for evaluation at least one lesion; 7. ECOG PS score 0-1; 8. Estimated survival = 12 weeks; 9. Complete blood count: absolute neutrophil count (ANC) = 1.5×109/L, platelet count = 100×109/L, hemoglobin =9 g/dl; 10. Blood biochemical tests: serum albumin = 2.9 g/dl, total bilirubin = 1.5 × ULN, ALT and AST = 2.5 × ULN, serum creatinine = 1.5 × ULN 11. Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) =1.5 × ULN; 12. Patients with active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be <2000 IU/ ml, and have received at least 14 days of anti-HBV therapy (according to local standard therapy, e.g., entecavir) prior to the start of study treatment and are willing to receive antiviral therapy throughout the study; hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must be on antiviral therapy according to local standard of care guidelines and have liver function within CTCAE grade 1 elevation; 13. Non-surgically sterile or female patients of childbearing potential who are required to use one medically approved contraceptive measure (such as an intrauterine device, birth control pill, or condom) during study treatment and for 3 months after the end of the study treatment period, non-surgically sterilized female patients of childbearing potential must have a negative serum or urine HCG within 7 days prior to study enrollment and must be non-lactating, and non-surgically sterile or male patients of childbearing potential who agree to use one medically approved contraceptive measure with their spouse during study treatment and for 3 months after the end of the study treatment period. 14. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors at the same time or within 5 years should be excluded, but localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. can be enrolled; 2. Patients with autoimmune diseases; 3. Patients who are ready for organ transplantation or have previously received organ transplantation or allogeneic bone marrow transplantation; 4. Severe or refractory ascites (ascites Child-Pugh score equal to 3); 5. History of gastrointestinal bleeding or obvious gastrointestinal bleeding tendency within 6 months before the start of the study, such as esophageal and gastric varices at risk of bleeding, active local ulcers, and persistent positive fecal occult blood; 6. Thrombotic or embolic events within 6 months prior to the start of study treatment; 7. Previous history of allergy to any ingredient of Tegio capsules, camrelizumab, and apatinib mesylate tablets; 8. Those with a variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 9. Clinically symptomatic central nervous system metastases such as cerebral edema, requiring hormonal intervention, or progression of brain metastases. Patients who have received prior treatment for brain or meningeal metastases, such as those shown on MRI and clinically stable (not requiring greater than 10 mg/day of prednisone or equivalent dose of hormonal therapy), may be included; 10. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade II or above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 11. Received any of the following treatments: a) Receipt of any investigational drug within 4 weeks prior to the first use of study drug; b) Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; c) Receipt of the last dose of anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks prior to the first dose =of study drug; d) Subjects who require systemic treatment with corticosteroids (> 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to the first dose of study drug, except for the use of corticosteroids for local inflammation and prevention of allergies and nausea and vomiting. In other special circumstances, it is necessary to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical sterols and adrenocorticosteroid replacement at a dose of > 10 mg/day efficacy dose of prednisone are permitted; e) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first dose of study drug; f) Major surgery or severe trauma within 4 weeks prior to the first use of study drug; 12. Toxicity from prior antineoplastic therapy that has not recovered to = CTCAE Grade 1 (except for alopecia, sequelae of prior platinum-based therapy-related neurotoxicity) or the level specified by the enrollment/exclusion criteria; 13. Severe infection (CTCAE> grade 2) within 4 weeks prior to the first use of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Progression Free Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhu Qing
West China Hospital, Sichuan University
Outcome results
None listed