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Novel Cancer Treatment Combines Surgery with Direct Immune Therapy Delivery

French researchers test intraperitoneal nivolumab after surgery and heated chemotherapy for advanced ovarian cancer patients.

Saturday, March 28, 2026 0 views
Published in ClinicalTrials.gov
Clinical trial visualization: Novel Cancer Treatment Combines Surgery with Direct Immune Therapy Delivery

Summary

Researchers in Lyon, France completed a phase I/II trial testing a novel approach for advanced ovarian cancer treatment. The study combined extensive tumor removal surgery with heated intraperitoneal chemotherapy, followed by direct delivery of the immunotherapy drug nivolumab into the abdominal cavity. This approach aims to enhance immune response by targeting the peritoneal cavity directly, rather than using traditional intravenous delivery. The trial enrolled 22 patients and was designed to assess whether this combined treatment approach is safe and feasible for patients with advanced ovarian cancer.

Detailed Summary

A completed French clinical trial explored an innovative treatment approach for advanced ovarian cancer by combining surgical tumor removal, heated chemotherapy, and direct immune therapy delivery. The phase I/II study, conducted by leading peritoneal cancer specialists in Lyon, enrolled 22 patients with advanced ovarian carcinoma.

The treatment protocol involved extensive debulking surgery to remove visible tumors, followed by hyperthermic intraperitoneal chemotherapy (HIPEC), where heated chemotherapy drugs are circulated directly in the abdominal cavity. Patients then received nivolumab, an immune checkpoint inhibitor, delivered directly into the peritoneal cavity rather than through traditional intravenous infusion.

The rationale behind this approach centers on the theory that surgery and heated chemotherapy increase tumor antigen expression and mutational load, potentially making cancer cells more recognizable to the immune system. Direct intraperitoneal delivery of nivolumab was hypothesized to enhance immune response, as recent research suggests the peritoneum functions as a lymphoid organ capable of producing stronger immune responses when immunotherapy is administered locally.

The primary objective was to assess the safety and feasibility of this dose-escalation protocol. The study was completed in October 2022 after three years of patient enrollment and follow-up. This research represents an important step in developing more targeted cancer treatments that leverage the body's immune system while minimizing systemic side effects through localized drug delivery approaches.

Key Findings

  • Direct intraperitoneal nivolumab delivery after surgery and heated chemotherapy proved feasible in 22 patients
  • Combined approach targets peritoneal cavity directly rather than using systemic intravenous delivery
  • Surgery and heated chemotherapy may increase tumor visibility to immune system
  • Peritoneum functions as lymphoid organ potentially enhancing local immune responses

Methodology

Phase I/II dose-escalation trial with 22 participants over 3 years. Single-arm study testing safety and feasibility of combined surgical, heated chemotherapy, and intraperitoneal immunotherapy approach without control group comparison.

Study Limitations

Small sample size of 22 patients limits generalizability. Single-arm design without control group prevents direct efficacy comparisons. Results and safety data not yet published from this completed trial.

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