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Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma

NCT05822453 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-20

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).

Conditions

  • Biliary Tract Carcinoma

Interventions

DRUG

Gemcitabine

Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle

DRUG

S1

S1 (60 mg/day if body surface area \< 1.25 m2, 80 mg/day if body surface area = 1.25\~1.50 m2) will be administered by PO on Day 1 \~ 14 of each 21-day cycle

DRUG

Tislelizumab

Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2025-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822453 on ClinicalTrials.gov