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RECRUITING
NCT06406816
EARLY_PHASE1

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

Sponsor: Yongyi Zeng

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-05-06

Completion Date

2026-05

Last Updated

2025-05-15

Healthy Volunteers

No

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.

Locations (1)

Mengchao Hepatobiliary Hospital, Fujian Medical University

Fuzhou, Fujian, China