HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-L1 inhibitor, HAIC.
- Who it may be relevant to
- Registry conditions: ICC, Advanced Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial
Overview
Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.
Detailed description
Hepatic arterial infusion chemotherapy (HAIC)-GC（Gemcitabine+Cisplatin） combined with Durvalumab OR Pembrolizumab
Interventions
- Drug PD-L1 inhibitor
PD-L1 inhibitor Drug: Durvalumab OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab: During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 200 mg Q4W - Procedure HAIC
Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: Cisplatin 20mg/m2, maintained for 3 hours. Gemcitabine 0.6g/m2, maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: 2 year]
Secondary outcome measures (2)
- Overall Survival (OS) [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
- Progression-free Survival (PFS) [Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Eligibility criteria
Inclusion criteria
- Age: Age ≥ 18 years old.
- Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.
- Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).
- Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.
- Expected lifespan: Expected lifespan ≥ 3 months.
- Liver function: Child Pugh classification A or B.
- Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.
- Not receiving relevant treatment: Not receiving systematic treatment for ICC.
Exclusion criteria
- Previous treatment: Previously received systemic treatment for ICC.
- Poor physical condition: ECOG physical condition score ≥ 2.
- Poor liver function: Child Pugh grading>8.
- Short life expectancy: Life expectancy is less than 3 months.
- Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.
- Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.
- Drug allergy or intolerance: Allergic to the investigational drug or its excipients.
- Other: Other situations that the researcher deems unsuitable to participate in this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Eastern Hepatobiliary Surgery Hospital — Shanghai
Identifiers
NCT: NCT07364305 · Lalo · 20241130