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NOT YET RECRUITING

NCT05648487

PHASE2

HIPEC Combined With Sintilimab for Gastric Cancer With Peritoneal Metastasis

Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

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

Official title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Sintilimab in Gastric Cancer With Peritoneal Metastasis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-01

Completion Date

2027-12-31

Last Updated

2022-12-16

Healthy Volunteers

Conditions

Gastric Cancer

Interventions

DRUG

HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery

1. 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. 2. 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. 3. Surgery: Imaging and secondary surgical exploration, assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases). For patients undergoing surgery, HIPEC for three cycles followed, 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 of guidelines recommend. 4. After the surgery, continue to use standard adjuvant chemotherapy.

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;