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Combination Therapy of GCNT and Tislelizumab in Advanced Biliary Tract Cancer

NCT06893380 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2025-09-15

No results posted yet for this study

Summary

This is a multicenter Phase 1b/2 clinical trial investigating the efficacy and safety of a combination regimen of Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab in treatment-naïve patients with unresectable, locally advanced, or metastatic biliary tract cancers (BTC), including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.

The Phase 1b portion aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Nab-paclitaxel in combination with Gemcitabine, Cisplatin, and Tislelizumab. In the Phase 2 portion, the study will evaluate the Objective Response Rate (ORR) as the primary endpoint, with additional assessments of Overall Survival (OS), Progression-Free Survival (PFS), Disease Control Rate (DCR), and Quality of Life (QoL). Safety and tolerability will also be closely monitored.

This study seeks to leverage the stromal-disrupting effect of Nab-paclitaxel and the immune checkpoint blockade effect of Tislelizumab, combined with the established chemotherapy backbone of Gemcitabine and Cisplatin, to enhance treatment outcomes for BTC patients. The study will enroll patients across three medical centers in South Korea, including CHA Bundang Medical Center, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.

Conditions

  • Locally Advanced Biliary Tract Cancers
  • Metastatic Biliary Tract Cancers

Interventions

DRUG

Gemcitabine, Cisplatin, Nab-paclitaxel, and Tislelizumab.

Tislelizumab: IV 200mg on Day 1 of every 3-week cycle Nab-paclitaxel: IV 75mg/m2 on Days 1 and 8 of every 3-week cycle (up to 16 cycles) Gemcitabine: IV 800mg/m2 on Days 1 and 8 of every 3-week cycle Cisplatin: IV 25mg/m2 on Days 1 and 8 of every 3-week cycle (up to 8 cycles)

Sponsors & Collaborators

  • CHA University

    lead OTHER

Principal Investigators

  • Hong Jae Chon, MD. PhD · Principal Investigator

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-05-08
Completion
2026-12-31

Countries

  • South Korea

Study Locations

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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 NCT06893380 on ClinicalTrials.gov