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

Sponsor
Shanghai Changzheng Hospital
Study ID
NCT07621484
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperthermic Intraperitoneal Chemotherapy — PROCEDURE
    Docetaxel-based hyperthermic intraperitoneal chemotherapy administered after diagnostic laparoscopy in patients with P0/CY0 locally advanced gastric cancer
  • Serplulimab — DRUG
    Serplulimab administered intravenously every 3 weeks as part of neoadjuvant treatment
  • S-1 — DRUG
    Oral S-1 administered during neoadjuvant treatment.
  • Capecitabine — DRUG
    Oral capecitabine administered during neoadjuvant treatment.
  • Oxaliplatin — DRUG
    Intravenous oxaliplatin administered as part of SOX/XELOX neoadjuvant chemotherapy.
  • Radical Gastrectomy — PROCEDURE
    Standard radical gastrectomy with D2 lymphadenectomy performed after completion of neoadjuvant therapy.

Study Details

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.

Key Dates

First listed
Jun 2, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
May 9, 2028
Completion
May 9, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Participants will undergo diagnostic laparoscopy with peritoneal lavage cytology followed by docetaxel-based hyperthermic intraperitoneal chemotherapy (HIPEC). After recovery from HIPEC, patients will receive one induction cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX/XELOX neoadjuvant chemotherapy prior to radical gastrectomy with D2 lymphadenectomy

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: At the time of surgery ]

Related Studies