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Neoantigen Vaccine Plus Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma After Radical Resection

NCT06406816 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-15

No results posted yet for this study

Summary

This study is a single-arm, open-label, exploratory clinical trial, with the primary objective to evaluate the efficacy and safety of the Neoantigen Vaccine plus capecitabine for the treatment of high-intermediate risk recurrent intrahepatic cholangiocarcinoma

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

COMBINATION_PRODUCT

Neoantigen Vaccine plus Capecitabine

1. Capecitabine.Twice a day, 30 minutes after breakfast, swallow with water, continue for 2 weeks, then stop for 1 week, constitutes one cycle; three weeks make one cycle, lasting for 8 cycles. 2. Neoantigen Vaccine . Every 3 weeks, once every 21 days, for 4 to 8 cycles. The injection is administered on the first day after cessation of capecitabine. Treatment can last for up to 6 months without occurrences such as the researcher determining no further clinical benefit, intolerable toxic reactions, initiation of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, death, or other circumstances specified in the protocol that require treatment termination.

Sponsors & Collaborators

  • Yongyi Zeng

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2026-05-31
Completion
2026-05-31

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 NCT06406816 on ClinicalTrials.gov