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NOT YET RECRUITING
NCT07902648
PHASE2

Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, multicenter, open-label, exploratory phase II clinical trial aimed at evaluating the efficacy and safety of serplulimab combined with DOS, lenvatinib, and PIPACS in patients with oligometastatic peritoneal metastases of gastric and gastroesophageal junction adenocarcinoma. A total of 42 patients diagnosed via laparoscopy with initially resectable gastric cancer accompanied by positive cytology in abdominal cavity washing solution and/or low-burden peritoneal metastases (peritoneal cancer index PCI ≤10) are planned to be enrolled to undergo serplulimab combined with DOS, lenvatinib, PIPACS, and surgical treatment.

Official title: Serplulimab, Docetaxel, Oxaliplatin, S1 and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma: A Single Arm Multicentre Clinical Trail

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-12-15

Completion Date

2028-12-31

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Serplulimab, Docetaxel, Oxaliplatin, S1, and Lenvatinib combined with PIPAC

First complete PIPAC surgical .The chemotherapy drug is albumin-bound paclitaxel, 10.5 mg/m² body surface area, dissolved in 150 mL solution . Transtomation therapy: Serplulimab + Lenvatinib + DOS therapy for 3+3 cycles, with evaluation every 3 cycles. After the end of the third cycle, if the evaluation shows CR/PR/SD, continue treatment for another 3 cycles. If the evaluation shows PD, the Sub-I will decide whether to change the regimen. After the 6th cycle, an evaluation will be conducted. If the evaluation indicates CR/PR/SD, surgery will be performed. If the evaluation indicates PD, the Sub investigator will decide whether to change the regimen. Adjuvant therapy: Serplulimab + Lenvatinib + DOS therapy for 2 cycles, followed by serplulimab combined with S1 maintenance therapy for 6 months. Serplulimab maintenance therapy can be continued up to 1 year post-surgery based on the patient's preference.