RecruitingEarly Phase 1NCT06406816

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


Sponsor

Yongyi Zeng

Enrollment

10 participants

Start Date

May 6, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a personalized cancer vaccine combined with a chemotherapy pill (capecitabine) can prevent intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) from coming back after surgery. The vaccine targets specific mutations unique to each patient's tumor. **You may be eligible if...** - You are 18 to 75 years old - You had surgery to remove bile duct cancer inside the liver (intrahepatic cholangiocarcinoma) - Your surgery showed high-risk features such as positive margins, lymph node involvement, large tumor size, or vascular invasion - Your liver function is good (Child-Pugh A, ECOG 0–1) - You have not yet started systemic therapy after surgery **You may NOT be eligible if...** - You received treatment before surgery (neoadjuvant therapy) - You already started post-surgery systemic treatment - You have active hepatitis B with detectable viral levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTNeoantigen 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

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NCT06406816


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