Infusion of checkpoint inhibitors and chemotherapy for advanced solid tumors

A Phase II/III Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of Advanced Solid Tumors

This study is testing if giving a mix of immune therapy and chemotherapy directly to tumors helps people with advanced cancers feel better compared to the usual way of giving these treatments.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: ipilimumab, Pembrolizumab, immunotherapy, doxorubicin
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT03755739 on ClinicalTrials.gov

What this trial studies

This trial investigates the safety and effectiveness of delivering checkpoint inhibitors and chemotherapy directly into tumors and through arteries in patients with advanced solid tumors. The approach aims to enhance drug concentration at the tumor site while minimizing systemic side effects. Patients with confirmed diagnoses of hepatocarcinoma, lung cancer, melanoma, renal cancer, and head and neck cancer will be treated with a combination of PD1/PDL1 antibodies and the chemotherapeutic drug ipilimumab. The study will compare the outcomes of this localized delivery method against traditional systemic administration.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with advanced solid tumors who have a life expectancy of more than three months and meet specific health criteria.

Not a fit: Patients with severe liver dysfunction, active bleeding, or those who have recently participated in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with advanced solid tumors.

How similar studies have performed: While localized delivery of immunotherapy is a novel approach, similar studies have shown promise in enhancing treatment efficacy for solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Cytohistological confirmation is required for diagnosis of cancer.
2. Signed informed consent before recruiting.
3. Age above 18 years with estimated survival over 3 months.
4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
5. Tolerable coagulation function or reversible coagulation disorders
6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L
7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
8. Birth control.
9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion Criteria:

1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
4. Patients accompanied with other tumors or past medical history of malignancy;
5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
6. Patients have poor compliance.

   Any contraindications for hepatic arterial infusion procedure:

   A.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%).

   B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
7. Allergic to contrast agent;
8. Any agents which could affect the absorption or pharmacokinetics of the study drugs
9. Other conditions that investigator decides not suitable for the trial.

Where this trial is running

Guanzhou, Guangdong

• The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Zhenfeng Zhang, MD,PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD,PhD

Conditions: Hepatocarcinoma, Lung Cancer, Melanoma, Renal Cancer, Head and Neck Cancer, Pancreas Cancer, Ovarian Cancer, Colo-rectal Cancer