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Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer

NCT06362317 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-04-12

No results posted yet for this study

Summary

Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers

Conditions

  • Biliary Tract Neoplasms Immunotherapy

Interventions

DRUG

Toripalimab

Toripalimab 240mg, intravenous infusion every 3 weeks until disease progression or occurrence of intolerable toxicity.

DRUG

Lenvatinib

When the body weight is ≥60 kg, the dosage of Lenvatinib is 12mg qd, when body weight \< 60kg the dosage is 8mg qd.

DRUG

Gemox Chemotherapy（Gemox or GC）

Chemotherapy drugs: GC regimen is preferred, and if patients cannot tolerate it, GEMOX regimen is used. Gemcitabine + oxaliplatin (GEMOX) regimen chemotherapy: every 21 days (3 weeks), 1000 mg/m2 of gemcitabine was administered intravenously for more than 30 min on the 1st and 8th day, and 100 mg/m2 of oxaliplatin was administered intravenously for 2h on the 1st day Gemcitabine + cisplatin (GC) regimen chemotherapy: 1250 mg/m2 was administered intravenously for 30 min on day 1 and day 8, respectively, and 100 mg/m2 was administered intravenously for 2 hours after gemcitabine treatment on day 1.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2025-03-06
Completion
2026-03-06

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 NCT06362317 on ClinicalTrials.gov