Sintilimab in Combination With S-1/Oxaliplatin With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites

NCT06046963 | Unknown Phase 2

• 1 other identifier: IRB-2023-704
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Sintilimab in Combination With S-1/oxaliplatin With nab-paclitaxel intraperitoneal infusion as First-line Treatment for advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites

Conditions

Gastric Cancer; Peritoneal Metastases; Ascites, Malignant

Keywords

Malignant ascites; Gastric Cancer; Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• Ascites objective response rate (ORR)

  The ascites objective response rate (ORR) was calculated as a summed ratio of patients with disappeared and decreased ascites to the total number of patients.

  1 year

Secondary Outcomes (6)

• Overall Survival (OS)

  1 year

• Progress free survival (PFS)

  1 year

• 12 months os rate

  1 year

• Obiective response rate of Solid tumor lesion (if exists)

  1 year

• Safety assessment

  1 year

Study Arms (1)

Immunotherapy combined with intravenous and intraperitoneal chemotherapy

EXPERIMENTAL

advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma patients with malignant ascites who have agreed to receive Immunotherapy combined with intravenous and intraperitoneal chemotherapy

Drug: Sintilimab in Combination With S-1/oxaliplatin With nab-paclitaxel intraperitoneal infusion; Other: Blood samples, tumor biopsy specimens, ascites, and feces samples will be collected

Interventions

Sintilimab in Combination With S-1/oxaliplatin With nab-paclitaxel intraperitoneal infusion DRUG

Sintilimab: 200 mg, intravenous infusion, d1, q3w; Nab-paclitaxel: 100 mg/m2 intraperitoneal infusion, d1, q3w; S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w; Oxaliplatin: 130 mg/m2, intravenous infusion, d1, q3w; The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects wil continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of informed Consent Form, or termination in the investigator's judgment.

Immunotherapy combined with intravenous and intraperitoneal chemotherapy

Blood samples, tumor biopsy specimens, ascites, and feces samples will be collected OTHER

Blood samples, tumor biopsy specimens, ascites, and feces samples will be collected at diferent time points (if feasible, according to the samples taken in the standard practice): at Baseline; After 1-2 cycles of treatment; at the time of the progression or recurrence, if applicable.

Immunotherapy combined with intravenous and intraperitoneal chemotherapy

Eligibility Criteria

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

You may qualify if:

• Have fully understood the research and voluntarily signed the informed consent;
• Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by pathology, and unresectable advanced or metastatic disease;
• HER2 negative, mismatch repair-proficient (pMMR);
• Moderate or above volume of ascites at baseline;
• Peritoneal metastasis confirmed by ascites cytology or laparoscopy;
• Aged from 18 to 75 years old, regardless of gender;
• Within 7 days before the first administration of the study drug, the ECOG score is 0-2;
• Expected survival period ≥ 3 months;
• Adequate organ function:
• Routine Blood Test: (no blood transfusion, no use of granulocyte colony-stimulating factor \[G-CSF\], no drug correction within 14 days prior to screening):
• Neutrophils ≥ 1.5×109/L;
• Platelets ≥ 75×109/L;
• Hemoglobin ≥ 90g/L;
• Biochemical examination: (No albumin infusion within 14 days before screening):
• Serum creatinine ≤ 1.5 × upper limit of normal ULN, or creatinine clearance \> 50 mL/min;

You may not qualify if:

• HER2-positive (IHC3+ or IHC2+ and FISH-positive at the same time) or dMMR/MSI-H;
• Previously received systemic therapy for advanced unresectable or metastatic GC/GEJ adenocarcinoma. Patients can previously receive neoadjuvant therapy or adjuvant therapy, as long as it ends at least 6 months before this diagnosis without progress;
• Previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists, immune cell therapy and other immunotherapy.
• Previously received intraperitoneal chemotherapy, including hyperthermic intraperitoneal chemotherapy (HIPEC), pressurized intraperitoneal aerosol chemotherapy (PIPAC), intraperitoneal chemotherapy, etc.
• Other active malignant tumors other than GC/GEJ adenocarcinoma within 5 years or at the same time. Localized tumors that have been cured can be enrolled, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc.;
• Uncontrolled or moderate and above pleural effusion, pericardial effusion;
• Hemorrhagic events that require blood transfusion, invasive intervention or hospitalization occurred within 3 months before the first administration, or currently have bleeding symptoms and require intervention (such as hemoptysis, hematuria, bloody stool);
• Thrombosis or embolism events occurred within 6 months before the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.;
• Received major surgical treatment (except for diagnosis) within 4 weeks before the start of study treatment or expected major surgical treatment during the study period;
• Inability to swallow tablets, malabsorption syndrome, complete intestinal obstruction and other conditions affecting gastrointestinal absorption;
• There have been or are currently central nervous system metastases;
• Active autoimmune disease or history of autoimmune disease and possible relapse;
• Using immunosuppressant or systemic hormone therapy within 14 days before starting the study treatment to achieve the purpose of immunosuppression;
• Patients with congenital or acquired immune deficiency (such as HIV infection);
• Received attenuated live vaccine treatment within 28 days before starting the study treatment, or need to receive such vaccine during the expected treatment or within 60 days after the last dose;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Ascites

Interventions

sintilimab; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jieer Ying, Dr

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Ni, Dr

CONTACT

15088667597; 3140102210@zju.edu.cn

Jieer Ying, Dr

CONTACT

13858195803; jieerying@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: oepn label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 21, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)