Clinical trial NCT05648487: HIPEC Combined With Sintilimab for Gastric Cancer With Peritoneal Metastasis
Official title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Sintilimab in Gastric Cancer With Peritoneal Metastasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Peritoneal Metastasis
HIPEC
PD1
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: R0 resection
timeFrame: 3 months
Secondary outcomes:
measure: Overall survival time
timeFrame: 2 years
measure: ORR
timeFrame: 3 months
measure: Event-Free Survival
timeFrame: 2 years
measure: Relapse-Free Survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Shuzhong Cui, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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