NCT05156788

Tislelizumab（Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

A Single-arm, Multi-center, Phase II Study of Tislelizumab, Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC.

Detailed description

Translational therapy refers to methods such as chemotherapy, radiotherapy, immunotherapy, targeted and combined therapy to shrink tumors, reduce tumor biological behavior, and achieve secondary resection. The success rate of transformation depends on the objective response rate of the treatment method (Objective response rate, ORR). The latest review showed that 132 patients with unresectable ICC had undergone chemotherapy, chemoembolization, radiotherapy embolization or combination therapy, and 27 patients received downgrade resection. The research of our group using PD-1 antibody combined with lenvatinib and Gemox chemotherapy in the first-line treatment of unresectable advanced cholangiocarcinoma (NCT03951597, 2020ESMO, 2021ASCO) showed that the ORR was 80% and the disease control rate (DCR) It reached 93.3% (28/30), of which 3 cases underwent successful radical resection after downstage. These data suggest that PD1 monoclonal antibody combined with lenvatinib and Gemox chemotherapy may be an ideal conversion therapy for patients with potentially resectable advanced biliary system tumors, but there is currently no evidence-based basis. This study explores the efficacy and safety of PD1 monoclonal antibody combined with Lenvatinib and Gemox chemotherapy in potentially resectable advanced BTC conversion therapy. It has certain clinical significance in order to increase the R0 surgical resection rate of BTC patients and improve patient survival.

Conditions

• Biliary Tract Cancer
• PD-1 Antibody
• Gemox
• Lenvatinib

Interventions

Type	Name	Description
DRUG	PD-1+Lenvatinib+GEMOX	Tilelizumab 200mg, add 0.9% NS 100mL, d1 Q3W, Lenvatinib 8mg, po, qd Gemox chemotherapy: Gemcitabine 1000mg/m2 with 0.9% NS 100mL, 30 minutes, d1, 8, Q3W, + oxaliplatin 85mg/m2 with 5%GS 500mL, 2 hours, d1, Q3W

Timeline

• Start date: 2021-12-12
• Primary completion: 2023-07-03
• Completion: 2025-10-01
• First posted: 2021-12-14
• Last updated: 2023-08-15

Locations

2 sites across 1 country: China