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PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.

NCT05207735 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-01-26

No results posted yet for this study

Summary

This is a single-center, single-arm, prospective phase II clinical study to evaluate the effectiveness and safety of Sintilimab combined with capecitabine in patients after radical resection of cholangiocarcinoma.

The primary endpoint of the study:

• 2-year recurrence-free survival rate

Secondary endpoint:

• Overall survival (OS), 1y RFS%, 2y OS%, 3y OS%, time to recurrence (TTR), RFS;Safety and tolerability.

Study drugs, dosages, and methods of administration:

* Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles.
* Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.

Conditions

Interventions

DRUG

Sintilimab

* Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles. * Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Jinxue Zhou, MD · Henan cancer hospital,affiliated cancer hospital of zhengzhou university

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
2022-01-31
Primary Completion
2023-12-31
Completion
2024-12-31

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Entities

Diseases

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 NCT05207735 on ClinicalTrials.gov