Clinical trial · Interventional
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
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: H-FROG Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Famitinib malate | Drug | — | UNRESOLVED |
| Gemcitabine & oxaliplatin | Drug | — | UNRESOLVED |
| hepatic arterial infusion chemotherapy (HAIC) | Procedure | — | UNRESOLVED |
| Rilvegostomig Alpha | Drug | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined treatment group
- description
- Participants in this single arm will receive perioperative treatment with rilvegostomig alpha, famitinib malate, and HAIC-GEMOX before surgery, followed by postoperative adjuvant therapy with rilvegostomig alpha plus capecitabine or S-1 when applicable.
- interventionNames
- Drug: Rilvegostomig Alpha
- Drug: Famitinib malate
- Drug: Gemcitabine & oxaliplatin
- Drug: Capecitabine
- Drug: S-1
- Procedure: hepatic arterial infusion chemotherapy (HAIC)
Primary outcomes (1)
- measure
- Event-free survival (EFS)
- timeFrame
- From the start of treatment until the first EFS event, assessed up to 36 months.
- description
- EFS is defined as the time from the start of treatment to the first occurrence of any event, including disease progression that precludes surgery, local or distant recurrence, or death from any cause.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
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