Recruiting

Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial

ClinicalTrials.gov IDNCT07847710

PhasePHASE2

Enrollment81

SponsorThe First Affiliated Hospital with Nanjing Medical University

Age18 Years – 75 Years

SexALL

I'm interested View official listing

Conditions studied

Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy

About this study

This is a multicenter, single-arm, exploratory clinical study for adults with locally advanced intrahepatic cholangiocarcinoma (ICC) that may be technically resectable but is difficult to remove directly by surgery. The study will evaluate whether perioperative treatment with Retlirafusp alfa, famitinib malate, and hepatic arterial infusion chemotherapy using gemcitabine and oxaliplatin (HAIC-GEMOX) can help control the tumor before surgery and support further treatment after surgery. Participants who meet the study requirements will receive neoadjuvant treatment before surgery. After surgery, participants will receive adjuvant treatment with Retlirafusp alfa combined with capecitabine or S-1. The study treatment and follow-up will continue until disease progression, unacceptable side effects, death, withdrawal of consent, or other protocol-defined stopping criteria. The main purpose of the study is to evaluate event-free survival. The study will also monitor tumor response, surgery-related outcomes, survival, and safety. Participants will have regular safety visits, blood tests, imaging examinations, and follow-up visits during and after treatment.

Interventions

Drug: Rilvegostomig Alpha — 30 mg/kg, i.v., q3w, Day 1 of each 3-week cycle.
Drug: Famitinib malate — 10 mg, orally, once daily.
Drug: Gemcitabine & oxaliplatin — hepatic arterial infusion, Day 1 of each 3-week cycle.
Drug: Capecitabine — 1250 mg/m², orally twice daily, Days 1-14 of each 3-week cycle, as postoperative adjuvant therapy.
Drug: S-1 — 40 mg/m², orally twice daily, Days 1-28 of each 6-week cycle, as postoperative adjuvant therapy.
Procedure: hepatic arterial infusion chemotherapy (HAIC) — Hepatic arterial infusion chemotherapy with gemcitabine and oxaliplatin administered on Day 1 of each 3-week cycle.

Primary outcomes

Event-free survival (EFS) (From the start of treatment until the first EFS event, assessed up to 36 months.)

Eligibility information

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

Study locations

The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.