Perioperative therapy with Retlirafusp alfa, Famitinib, and HAIC-GEMOX for locally advanced intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase II study enrolling adults with locally advanced intrahepatic cholangiocarcinoma that is technically resectable but difficult to remove by surgery. Participants receive neoadjuvant therapy with Retlirafusp alfa, famitinib, and HAIC-GEMOX, followed by surgery when feasible and adjuvant therapy with Retlirafusp alfa plus capecitabine or S-1. The primary endpoint is event-free survival, with secondary monitoring of tumor response and surgical outcomes. Treatment and follow-up continue until progression, unacceptable toxicity, withdrawal, or other stopping criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all of the following criteria:

1. Voluntarily agree to participate in the study and sign the informed consent form.
2. Age 18 to 75 years at the time of signing informed consent, male or female.
3. Histologically and/or cytologically confirmed intrahepatic cholangiocarcinoma.
4. ECOG performance status of 0 to 1.
5. No prior systemic therapy or tumor-related surgery, except biliary drainage.
6. No extrahepatic metastasis.
7. Considered technically resectable by an experienced hepatobiliary surgeon.
8. At least one measurable lesion according to RECIST 1.1.
9. Adequate organ and bone marrow function, as defined by the protocol.
10. Women of childbearing potential must have a negative serum pregnancy test within 7 days before treatment and agree to use effective contraception during the study and for 1 year after the last study treatment. Male participants with partners of childbearing potential must also agree to use effective contraception during the study and for 1 year after the last study treatment.
11. Life expectancy of at least 12 weeks.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

1. Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components.
2. Prior systemic therapy or other tumor-related treatment, except biliary drainage.
3. Diagnosis of any other malignancy within 5 years before the first study treatment, except cured localized tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, or low-grade prostate cancer.
4. Known uncontrolled pulmonary fibrosis, interstitial lung disease, or acute lung disease.
5. Participation in another clinical trial of an investigational drug or device within 4 weeks before the first study treatment.
6. Active hepatitis B or hepatitis C infection.
7. Active autoimmune disease requiring systemic treatment within 2 years before the first

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Lu Ling Professor Lu, MD
• Email: lvling@njmu.edu.cn
• Phone: +86 13813882571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.