Tislelizumab+Lenvatinib+Gemox Regiment for Potentially Resectable Locally Advanced Malignant Tumors of Biliary System.

NCT05036798 | Unknown Phase 2

• 1 other identifier: GDS20210220320615
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open, Phase II clinical study of Tislelizumab combined with lenvatinib and Gemox regimen for transformational treatment of potentially resectable locally advanced malignant tumors of biliary system.

Conditions

Potentially Resectable Locally Advanced Malignant Tumors of Biliary System

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  5 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  18 months

• Disease control rate (DCR)

  5 months

• Objective response rate (ORR)

  5 months

• Overall survival (OS)

  24 months

• Improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)

  24 months

Study Arms (1)

Tislelizumab combined with Lenvatinib and GEMOX

EXPERIMENTAL

Chemotherapy regimen(GEMOX): Gemcitabine 1g/m2,Oxaliplatin 100mg/m, D1, Q3W Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD Receive at least 3 cycles of combined treatment, and perform imaging evaluation after 3 cycles of treatment. If surgical treatment is not possible, imaging evaluation will be performed every two cycles thereafter until surgical treatment is feasible. If more than 7 cycles are still not possible for surgical resection, enter Tislelizumab + Lenvatinib maintenance treatment until the disease progresses or the toxicity cannot be tolerated. If patients undergoing R0 resection, start to receive Tislelizumab + Lenvatinib+Gemox regimen in 4-8 weeks after surgery for 7 cycles, and then entered Tislelizumab+Lenvatinib for 1 year or disease progression or toxicity cannot be tolerated

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Chemotherapy regimen: Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2 Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD

Also known as: Lenvatinib, Gemox

Tislelizumab combined with Lenvatinib and GEMOX

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histological diagnosis of potentially resectable local advanced biliary malignancies (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma);
• Potential resectable criteria: The first-stage R0 resection cannot be guaranteed for patients with cholangiocarcinoma admitted to our hospital, and there are the following imaging characteristics (satisfy one or more) :
• The hilar and retroperitoneal lymph nodes were considered for metastasis but could be resected completely.
• Intrahepatic cholangiocarcinoma has multiple foci, but foci are less than three and limited to half of the liver.
• Local progression of gallbladder carcinoma with colon or duodenal involvement.
• Hilar cholangiocarcinoma or lower segment of cholangiocarcinoma involving portal vein or hepatic artery requires combined vascular resection or reconstruction; 2. Patient age 20-79 years; 3. At least one measurable lesion as defined in RECIST version 1.1; 4. ECOG score was 0-1; 5. No prior medical treatment; 6. Adequate organ and bone marrow function and laboratory tests meet the following requirements:
• HGB≥90g/L；
• NEUT≥1.5×109/L；
• PLT ≥100×109/L；
• TBIL≤1.5 times normal upper limit (ULN);
• ALT and AST ≤2.5 x ULN;ALT and AST≤5×ULN for liver metastasis;
• Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
• Urinary protein \< (++), or 24 hours urinary protein \<1.0 g; 7. Coagulation was normal without active bleeding
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• International standardized ratio INR≤1.5;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

tislelizumab; lenvatinib; gemcitabine-oxaliplatin regimen

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: September 17, 2021
• Primary Completion: July 2, 2022
• Study Completion: December 30, 2023
• Last Updated: September 7, 2022

Record last verified: 2022-08

Locations

CN (1)