A Phase 2 interventional study of Rilvegostomig Alpha and Famitinib malate in Intrahepatic Cholangiocarcinoma (Icc) and Neoadjuvant Therapy, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
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.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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.
Drug: Rilvegostomig Alpha · Drug: Famitinib malate · Drug: Gemcitabine & oxaliplatin · Drug: Capecitabine · Drug: S-1 · Procedure: hepatic arterial infusion chemotherapy (HAIC)
30 mg/kg, i.v., q3w, Day 1 of each 3-week cycle.
Also known as: shr-1701
10 mg, orally, once daily.
Also known as: Famitinib
hepatic arterial infusion, Day 1 of each 3-week cycle.
Also known as: GEMOX
1250 mg/m², orally twice daily, Days 1-14 of each 3-week cycle, as postoperative adjuvant therapy.
40 mg/m², orally twice daily, Days 1-28 of each 6-week cycle, as postoperative adjuvant therapy.
Hepatic 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.
Time frame: From the start of treatment until the first EFS event, assessed up to 36 months.
Pathological complete response rate
Percentage of participants who achieve pathological complete response after neoadjuvant treatment and surgery.
Time frame: At the time of surgical pathological assessment, assessed up to 36 months.
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.
Time frame: At the time of surgical pathological assessment, assessed up to 36 months.
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.
Time frame: At the time of surgery, assessed up to 36 months.
Disease-free survival
DFS is defined as the time from the date of surgery to disease recurrence or death from any cause.
Time frame: From the date of surgery until recurrence or death, assessed up to 36 months.
Overall survival
OS is defined as the time from the start of neoadjuvant treatment to death from any cause or the date of last follow-up.
Time frame: From the start of neoadjuvant treatment until death or last follow-up, assessed up to 36 months.
Incidence and severity of adverse events
Safety will be assessed by the incidence and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0, as well as changes in vital signs, laboratory test results, and quality-of-life scores.
Time frame: From the start of treatment through the safety follow-up period, assessed up to 36 months.
Plan to share: Undecided
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The First Affiliated Hospital with Nanjing Medical University