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Clinical Study on the First-line Treatment of Advanced Biliary System Tumors With Tripley Monoclonal Antibody Combined With GEMOX Regimen

NCT04191343 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-09

No results posted yet for this study

Summary

This is an open, single-arm, single-center, prospective phase II clinical study to evaluate the efficacy and safety of first-line tripletrumab combined with GEMOX chemotherapy in patients with advanced biliary tract tumors.

Selected patients will receive the following treatment:

Triplel monoclonal antibody (240mg, intravenous drip, d1, q3w);Combined with gemcitabine (1000mg/m2, intravenous drip, d1, d8, q3w) and oxaliplatin (100mg/m2, intravenous drip, d1, q3w) until the disease progresses or an intolerable adverse reaction occurs (the maximum treatment time is 2 years).

Conditions

  • Advanced Biliary Tract Tumors

Interventions

DRUG

Toripalimab injection combined with GEMOX

Toripalimab Injection (240mg, intravenous drip, d1, q3w);Combined with gemcitabine (1000mg/m2, intravenous drip, d1, d8, q3w) and oxaliplatin (100mg/m2, intravenous drip, d1, q3w)

Sponsors & Collaborators

  • Zhejiang Cancer 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
2019-10-14
Primary Completion
2023-09-30
Completion
2024-06-30

Countries

  • China

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 NCT04191343 on ClinicalTrials.gov