GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma

NCT05668884 | Recruiting Phase 2

• 1 other identifier: 2209260-22-2407A
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase 2 study, the investigators aim to evaluate the effects and safety of combined therapy using oxaliplatin and gemcitabine chemotherapy, Donafenib and Tislelizumab for patients with advanced biliary tract carcinoma.

Conditions

Biliary Tract Carcinoma

Keywords

Donafenib; Tislelizumab; Effects; Safety

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  objective response rate(ORR)，defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1

  6 months

Secondary Outcomes (5)

• 1-year Recurrence free survival

  1 year

• Progression-free survival

  6 months

• Overall survival

  6 months

• Incidence and degree of Adverse Events and Serious Adverse Events

  6 months

• Conversion rate

  6 months

Study Arms (1)

experimental group

EXPERIMENTAL

Combination of Gemox, Donafenib and Tislelizumab

Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

Interventions

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab COMBINATION_PRODUCT

Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years;
• ECOG physical condition score: 0\~1;
• Histologically or cytologically confirmed advanced biliary tract carcinoma (including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma);
• Preoperative imaging assessment of the disease stage was III/IV;
• At least one measurable lesion (according to mRECIST criteria)
• Child-Pugh classification : A or B
• The main organs function well, and the examination indicators meet the following requirements:
• Routine blood tests: Hemoglobin ≥90 g/L (no blood transfusion within 14 days);Neutrophil count ≥1.5×10\^9/L; Platelet count ≥80×10\^9/L;
• Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula);
• thyroid function:Thyroid function is normal, thyroid stimulating hormone TSH is defined to be within the normal range. If baseline TSH is outside the normal range, T3 and T4 can be included if they are within the normal range;
• Myocardial enzyme profile:The myocardial enzyme profile was in the normal range (if simple laboratory abnormalities that were not clinically significant as determined by the investigators could also be included);
• Estimated survival time ≥ 3 months;
• Sign the informed consent voluntarily;
• Good compliance, and family members willing to cooperate with follow-up.

You may not qualify if:

• Patients with other uncured malignant tumors;
• Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
• Previous antitumor therapy for the disease in this study;
• Participated in clinical trials of other drugs within one month;
• Patients with a known history of other systemic serious diseases before screening;
• Obstructive jaundice (after active treatment such as biliary drainage or stent, the patients can be included in the group after the liver function returns to normal);
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the clinical laboratory of the study center);
• Active HCV infected persons (HCV antibody positive with HCV RNA levels above the lower limit of detection);
• Allergic to any investigational drug or excipient;
• Long-term unhealed wounds or incomplete healing fractures;
• Previous organ transplantation history;
• Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
• A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200062, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; donafenib; tislelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Yiming Zhao, M.D.

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Lu Wang, M.D.

CONTACT

86-18121299357; w.lr@hotmail.com

Yiming Zhao, M.D.

CONTACT

13917307629; gomas1711@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 30, 2022
• Study Start: October 18, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)