Clinical trial NCT04984980: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer
Official title: Efficacy and Safety of the Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Initially Unresectable Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Biliary Tract Carcinoma
Initially Unresectable
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Sample size: 34 patients; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 3 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 4.0; Follow up: 12 months after the last case was enrolled.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 and ≤80 years;
2. ECOG 0\~1;
3. Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;
4. Imaging assessment of disease stage III/IVA/any TN1M0\*;
5. The main organs have good functions and the examination indexes meet the following requirements:
6. Blood routine test:

   Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10\^9/L; Platelet count ≥80×10\^9/L;
7. Biochemical tests:

   Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula);
8. Voluntarily signed the informed consent;
9. Good compliance and family members are willing to cooperate with follow-up.

Exclusion Criteria:

1. Other uncured malignancies;
2. Pregnant or lactating women, if the subject becomes pregnant during the study period, should withdraw from the clinical trial;
3. Previous anti-tumor therapy for the disease in this study;
4. Participated in other drug clinical trials within one month;
5. Patients with known history of other systemic serious diseases before screening;
6. Long-term unhealed wounds or incomplete healed fractures;
7. Have a history of organ transplantation;
8. Abnormal blood coagulation, with bleeding tendency (14 days before randomization must meet: INR within the normal range without the use of anticoagulants); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for prophylactic purposes is permitted, provided that INR is less than 1.5;
9. The incidence of arterial/venous thrombosis events in the previous year, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism, was screened;
10. People with a history of psychotropic substance abuse and unable to get rid of it or with mental disorders; Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;

12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.

Primary outcomes:
measure: objective response rate
timeFrame: 3 weeks
Secondary outcomes:
measure: Safety：the incidence of adverse events and serious adverse events
timeFrame: 3 weeks
measure: disease control rate
timeFrame: 3 weeks
measure: progress-free survival
timeFrame: 3 weeks
measure: overall survival
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: