Combining DEB-TACE with Apatinib and PD-1 for treating advanced intrahepatic cholangiocarcinoma

Drug-eluting Beads Transarterial Chemoembolization Combined With Apatinib and PD-1 Antibody for the Treatment of Intrahepatic Cholangiocarcinoma That Has Progressed After Standard First-line Chemotherapy

This study is testing a new combination treatment of three drugs for patients with advanced bile duct cancer who haven't responded to standard chemotherapy to see if it can help them.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (Academic / other)
• Drugs / interventions: chemotherapy, carrelizumab, apatinib
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT04834674 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a combination treatment involving drug-eluting beads transarterial chemoembolization (DEB-TACE), apatinib, and a PD-1 monoclonal antibody for patients with intrahepatic cholangiocarcinoma (ICC) who have progressed after standard first-line chemotherapy. The study will enroll 20 patients and will follow a single-arm, open-label design. Participants will receive intravenous PD-1 antibody every 21 days, oral apatinib daily, and DEB-TACE treatment every 4-6 weeks, with monitoring throughout the treatment and follow-up periods. The goal is to assess the potential benefits of this combination therapy in a challenging-to-treat patient population.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with intrahepatic cholangiocarcinoma who have shown resistance to standard first-line chemotherapy.

Not a fit: Patients with evidence of hepatic decompensation or those with a history of organ allograft may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced intrahepatic cholangiocarcinoma who have limited treatment choices.

How similar studies have performed: While the combination of these therapies is novel, early clinical data on immune therapies for liver cancers suggest potential safety and efficacy.

Eligibility criteria

Inclusion Criteria:

1. The diagnosis of ICC
2. Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
3. Stand first-line chemotherapy resistance.
4. Performance status (PS) ≤ 2 (ECOG scale).
5. Child Pugh score ≤ 7.
6. Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
7. Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
8. Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan

Exclusion Criteria:

1. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
2. Known history of HIV
3. History of organ allograft
4. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
5. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
6. Evidence of bleeding diathesis.
7. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
8. Known central nervous system tumors including metastatic brain disease
9. Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
10. Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration.
11. Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.

Where this trial is running

Chengdu, Sichuan

• Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Guohui Xu

Conditions Intrahepatic Cholangiocarcinoma; Transarterial Chemoembolization; Apatinib; PD-1 Antibody