Clinical trial · Interventional
HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC
HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| ICC | Intrahepatic Cholangiocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAIC | Procedure | — | UNRESOLVED |
| PD-L1 inhibitor | Drug | PD-L1 Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HAIC combined with PD-L1 inhibitor
- description
- 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). 2. 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
- interventionNames
- Drug: PD-L1 inhibitor
- Procedure: HAIC
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age: Age ≥ 18 years old. 2. Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging. 3. Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria). 4. Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1. 5. Expected lifespan: Expected lifespan ≥ 3 months. 6. Liver function: Child Pugh classification A or B. 7. Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol. 8. Not receiving relevant treatment: Not receiving systematic treatment for ICC. Exclusion Criteria: 1. Previous treatment: Previously received systemic treatment for ICC. 2. Poor physical condition: ECOG physical condition score ≥ 2. 3. Poor liver function: Child Pugh grading\>8. 4. Short life expectancy: Life expectancy is less than 3 months. 5. Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors. 6. Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys. 7. Drug allergy or intolerance: Allergic to the investigational drug or its excipients. 8. Other: Other situations that the researcher deems unsuitable to participate in this study
References
Publications (0)
Data not yet available