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HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer

NCT07621484 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-07

No results posted yet for this study

Summary

Patients with locally advanced gastric cancer (LAGC), particularly those with serosal invasion, remain at high risk of peritoneal recurrence despite standard perioperative treatment. Hyperthermic intraperitoneal chemotherapy (HIPEC) may eradicate free intraperitoneal tumor cells and microscopic peritoneal disease while potentially enhancing systemic anti-tumor immune activation.

This is a prospective, single-center, single-arm exploratory study evaluating a HIPEC priming strategy followed by serplulimab-based neoadjuvant therapy in patients with locally advanced gastric cancer (cT3-4aN+M0). Eligible patients will undergo diagnostic laparoscopy confirming no visible peritoneal metastasis (P0) and negative peritoneal cytology (CY0), followed by docetaxel-based HIPEC.

After recovery from HIPEC, patients will initially receive one cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX/XELOX chemotherapy prior to radical gastrectomy.

The primary endpoints are pathological complete response (pCR) rate and major pathological response (MPR) rate. Secondary endpoints include R0 resection rate, objective response rate (ORR), peritoneal recurrence-free survival (PRFS), overall survival (OS), and safety.

Conditions

  • Locally Advanced Gastric Cancer
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

PROCEDURE

Hyperthermic Intraperitoneal Chemotherapy

Docetaxel-based hyperthermic intraperitoneal chemotherapy administered after diagnostic laparoscopy in patients with P0/CY0 locally advanced gastric cancer

DRUG

Serplulimab

Serplulimab administered intravenously every 3 weeks as part of neoadjuvant treatment

DRUG

S-1

Oral S-1 administered during neoadjuvant treatment.

DRUG

Capecitabine

Oral capecitabine administered during neoadjuvant treatment.

DRUG

Oxaliplatin

Intravenous oxaliplatin administered as part of SOX/XELOX neoadjuvant chemotherapy.

PROCEDURE

Radical Gastrectomy

Standard radical gastrectomy with D2 lymphadenectomy performed after completion of neoadjuvant therapy.

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-05-09
Completion
2028-05-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621484 on ClinicalTrials.gov