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Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers (BTC)

NCT06320301 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-03-20

No results posted yet for this study

Summary

Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study. The primary endpoint of the study was investigator-assessed 6-month progression-free survival (6-month PFS%) based on the RECIST v1.1 criteria, and 43 subjects were planned to be enrolled. Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor (TKI) in combination with gemcitabine and oxaliplatin (GEMOX).

Conditions

  • Biliary Tract Cancer
  • Gemox Chemotherapy

Interventions

DRUG

Adebrelimab + GEMOX + TKI

Adebrelimab 20 mg/kg, once every 3 weeks (Q3W), maintained for 1 year. The interval between two doses should not be less than 12 days. Tyrosine kinase inhibitor (TKI) Lenvatinib: 12 mg (3 capsules 4 mg) or 8 mg (2 capsules 4 mg) once daily (QD) at fixed times daily, on an empty stomach or with food; Apatinib: 250mg orally, QD, 5 days of medication, 2 days off (5 on 2 off) or once every other day (QOD), half an hour after meals; Sorafenib: 0.4g (2 × 0.2g) twice or once daily on an empty stomach or with a low-fat or medium-fat diet Anlotinib: 12 mg orally before breakfast, QD. The drug was taken continuously for 2 weeks and stopped for 1 week. GEMOX: gemcitabine 800mg/m2 and oxaliplatin 85mg/m2, intravenous infusion, D2, D15, D29, until 6 cycles of treatment were completed, or the patients who did not reach 6 cycles had intolerable adverse reactions, then the combination chemotherapy was terminated.

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-02-01
Completion
2026-06-01

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 NCT06320301 on ClinicalTrials.gov