NCT06406816

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Yongyi Zeng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-05-06
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-05-09
• Last updated: 2025-05-15

Locations

1 site across 1 country: China