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.
Voluntarily agree to participate in the study and sign the informed consent form.
Age 18 to 75 years at the time of signing informed consent, male or female.
Histologically and/or cytologically confirmed intrahepatic cholangiocarcinoma.
ECOG performance status of 0 to 1.
Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components.
Prior systemic therapy or other tumor-related treatment, except biliary drainage.
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.
Known uncontrolled pulmonary fibrosis, interstitial lung disease, or acute lung disease.
Single group
Rilvegostomig Alpha
Drug30 mg/kg, i.v., q3w, Day 1 of each 3-week cycle.
Famitinib malate
Drug10 mg, orally, once daily.
Gemcitabine & oxaliplatin
Drughepatic arterial infusion, Day 1 of each 3-week cycle.
Capecitabine
Drug1250 mg/m², orally twice daily, Days 1-14 of each 3-week cycle, as postoperative adjuvant therapy.
S-1
Drug40 mg/m², orally twice daily, Days 1-28 of each 6-week cycle, as postoperative adjuvant therapy.
hepatic arterial infusion chemotherapy (HAIC)
Procedure/SurgeryHepatic arterial infusion chemotherapy with gemcitabine and oxaliplatin administered on Day 1 of each 3-week cycle.
Event-free survival (EFS)
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.
Pathological complete response rate
Percentage of participants who achieve pathological complete response after neoadjuvant treatment and surgery.
Major pathological response rate
Percentage of participants who achieve major pathological response. Major pathological response is defined as residual viable tumor cells accounting for 50% or less of the tumor bed.
R0 resection rate
Percentage of participants who undergo R0 resection, defined as no gross residual tumor and no tumor cells within 1 mm of the microscopic surgical margin.
Disease-free survival
DFS is defined as the time from the date of surgery to disease recurrence or death from any cause.
Click on the lead sponsor to view all of their trials.
