Health TrialsbyHealthPanel

GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma

ConditionBiliary Tract Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

    Combination product

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

Treatment groups

93 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

1-year Recurrence free survival

1-year Recurrence free survival

Time frame
1 year
2

Progression-free survival

progression-free survival(PFS), defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

Time frame
6 months
3

Overall survival

overall survival(OS), defined as the time from enrollment to death due to any cause.

Time frame
6 months
4

Incidence and degree of Adverse Events and Serious Adverse Events

Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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