Combining HAIC with Durvalumab and Lenvatinib for Advanced Intrahepatic Cholangiocarcinoma
Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)
This study is testing a new treatment combining chemotherapy with two other drugs to see if it can help people with advanced bile duct cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | chemotherapy, durvalumab, lenvatinib |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06859684 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hepatic arterial infusion chemotherapy (HAIC) combined with durvalumab and lenvatinib as a first-line treatment for patients with locally advanced or metastatic intrahepatic cholangiocarcinoma. The approach aims to enhance local drug concentration while minimizing systemic side effects compared to traditional chemotherapy. By targeting patients with unresectable or metastatic disease, the study seeks to provide a more effective treatment option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma who have not received previous systemic treatment.
Not a fit: Patients with resectable disease or those who have received prior systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with advanced intrahepatic cholangiocarcinoma.
How similar studies have performed: While this approach is innovative, similar studies combining localized chemotherapy with immunotherapy and targeted therapy have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment. Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis 2. Disease recurrence \> 6 months after radical surgery; if adjuvant therapy is given after surgery, patients \> 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible for inclusion. 3. WHO/ECOG PS of 0 or 1 4. There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria Exclusion Criteria: 1. Patients who have received systemic treatment in the past. 2. Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome. 3. Patients with severe and uncorrectable coagulation dysfunction. 4. Patients with active hepatitis or severe infection who cannot be treated simultaneously. 5. Patients with cachexia or multiple organ failure.
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Yun X Zhang, PHD
- Email: zhangxiaoyun@wchscu.cn
- Phone: 18011410585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.