HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

NCT06213519 | Not Yet Recruiting Phase 2

• 1 other identifier: WCH-2023-1784
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prognosis of patients with peritoneal metastasis from gastric cancer is extremely poor. Although chemotherapy combined with immunotherapy has achieved promising efficacy in the first-line treatment of advanced gastric cancer, patients with peritoneal metastasis benefit less from this regimen. Hyperthermic intraperitoneal chemotherapy (HIPEC) represents a novel treatment option, which maintains the high concentration of drugs in the abdominal cavity, and improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma with peritoneal metastasis.

Conditions

Peritoneal Metastases; Gastric Cancer

Keywords

gastric cancer; peritoneal metastasis; HIPEC; first-line

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS) is defined as the time from randomization to death

  every 3 month postoperation up to 24 months

Secondary Outcomes (4)

• ORR

  every 3 month postoperation up to 24 months

• DCR

  every 3 month postoperation up to 24 months

• Progression-free survival

  every 3 month postoperation up to 24 months

• Safety and Tolerability

  every 3 month postoperation up to 24 months

Study Arms (1)

SOX+sintilimab+HIPEC

EXPERIMENTAL

Patient will receive SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA\<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA \< 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, and HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated in the second and third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.

Drug: S-1, Oxaliplatin sintilimab HIPEC

Interventions

S-1, Oxaliplatin sintilimab HIPEC DRUG

1. Exploratory laparoscopy or laparotomy 2. SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA\<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA \< 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. 3. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, 4. In the second and third cycles, HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated according to the patient's condition. 5. Another 3-cycle SOX regimen of systemic chemotherapy. 6. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.

SOX+sintilimab+HIPEC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological or cytological examination;
• No previous antitumor treatment.
• Agree to provide blood/tissue specimens.
• The expected survival is more than 3 months.
• ECOG PS≤1.
• Adequate organ function including the following:
• Total bilirubin ≤1.5 times the upper limit of normal (ULN);
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
• Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
• Serum creatinine≤1.5×ULN;
• Serum amylase and lipase≤1.5×ULN;
• International standardized ratio (INR)/partial thromboplastin time (PTT)≤1.5×ULN;
• Platelet count ≥ 75,000 /mm3;
• Hemoglobin (Hb) ≥ 9 g/dL;

You may not qualify if:

• Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
• Active autoimmune disease or history of refractory autoimmune disease.
• Receiving corticosteroids (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
• Active or clinically significant cardiac disease:
• Congestive heart failure \> New York Heart Association (NYHA) class 2;
• Active coronary artery disease;
• Arrhythmias requiring treatment other than β-blockers or digoxin;
• Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
• Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6 months prior to enrollment;
• Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
• Patients with pheochromocytoma.
• Patients with a history of HIV infection or active hepatitis B/C.
• Ongoing \> level 2 infection.
• Symptomatic brain metastasis or meningioma.
• Unhealed wounds, ulcers or fractures.

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Kun Yang, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongfeng Gou, M.D

CONTACT

+8618980602292; gouhongfeng@yeah.net

Pengfei Zhang, M.D.

CONTACT

+8617828163584; fly_121988@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 19, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share