HIPEC Combined With Sintilimab for Gastric Cancer With Peritoneal Metastasis

Phase 2

Not yet recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery

• Registration Number: NCT05648487
• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brief Summary

To evaluate the Safety and Efficacy of HIPEC Combined With Sintilimab for Gastric Cancer Patients with Peritoneal Metastasis.

Detailed Description

Peritoneal metastasis is the most common pattern of disease relapse and is attributed to the dismal prognosis of the gastric cancer. The National Comprehensive Cancer Network (NCCN) guidelines suggest that systemic chemotherapy is the first-line standard strategy, and chemotherapy combined with trastuzumab for patients with positive HER-2. HIPEC can significantly improve survival in peritoneal metastasis from gastric cancer. PD-1/PD-L1 antibody has shown promising outcomes for unresectable or metastatic solid tumors. The present study aimed to evaluate the safety and efficacy of HIPEC combined with Sintilimab (Tyvyt®) in gastric cancer patients with peritoneal metastasis.

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16
• Study Start: 2023-01-01
• Primary Completion: 2025-03-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
2. Age 18-75 years, Male or Non pregnant female
3. ECOG (Eastern Cooperative Oncology Group) : 0~1；
4. Negative for HER-2 by IHC/FISH；
5. Peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
6. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
7. Normal Bone marrow, liver and kidney function indices before the recruitment:
8. Expected survival≥ 12 week
9. Signed the Informed Consent Form, and blood and tissue samples can be obtained;

Exclusion Criteria

1. Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
2. Previous systemic therapy for gastric cancer;
3. Recurrent gastric cancer after surgery;
4. Cardiopulmonary dysfunction;
5. Immunosuppressive drugs(eg.Corticosteroids) were used within 14 days before treatment, eg.corticosteroids,
6. There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.)
7. Allergy to the drugs in this protocol；
8. Patients with other diseases not suitable for inclusion, such as immune deficiency, active tuberculosis, hepatitis B (non-active hepatitis B surface antigen (HBsAg) carriers, hepatitis B virus titer <500IU/ml after treatment and with normal liver function can be included), hepatitis C virus positive;
9. A history of idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia, or r active pneumonia;
10. Other patients who were considered unsuitable for inclusion by the researchers;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric Cancer With Peritoneal Metastasis, HIPEC, Anti-PD-1 Antibody	HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery	1. Surgical exploration, if PCI≤20, then we perform this study. 2. HIPEC: HIPEC is performed after laparoscopic exploration, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgical exploration; 3. Chemotherapy(SOX) and anti-PD-1 antibody Sintilimab (Tyvyt®) treatment followed (4 cycles): SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 4 cycles; Sintilimab (Tyvyt®) 200mg fixed dose every 3 weeks, for a total of 4 cycles. 4. Surgery: Imaging and secondary surgical exploration, assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). After the surgery, HIPEC for three cycles, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgery; For inoperable patients, continue to use standard chemotherapy. 5. After the surgery, continue to use standard adjuvant chemotherapy.

Primary Outcome Measures

Name	Time	Method
R0 resection	3 months	the rate of R0 resection

Secondary Outcome Measures

Name	Time	Method
ORR	3 months	Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR))/total number of subjects ×100%. Measurable lesion according to the RECISTv1.1
Event-Free Survival	2 years	Defined as the interval between the first conversion therapy and the first recorded related events, including preoperative disease progression, postoperative disease recurrence, and death from any cause.
Relapse-Free Survival	2 years	Defined as postoperative the first recorded postoperative recurrence of disease or death from any cause
Overall survival time	2 years	Overall survival time(OS) refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring.