Retlirafusp Alfa Plus SOX and Intraperitoneal Nab-Paclitaxel for Advanced Gastric/GEJ Cancer With Malignant Ascites

NCT07855757 | Active Not Recruiting

• 1 other identifier: IRB-2026-675
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of retlirafusp alfa in combination with SOX chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment for advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites, and to explore potential biomarkers associated with treatment response.

Conditions

Gastric Cancer (GC); Peritoneal Metastases From Gastric Cancer; 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 (8)

• 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)

Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel

EXPERIMENTAL

Patients will receive retlirafusp alfa 30 mg/kg IV, nab-paclitaxel 100 mg/m² intraperitoneally, and SOX chemotherapy every 3 weeks. SOX will be administered for up to 8 cycles, followed by retlirafusp alfa maintenance in eligible patients.

Drug: Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel

Interventions

Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel DRUG

Retlirafusp alfa 30 mg/kg IV, nab-paclitaxel 100 mg/m² intraperitoneally, and SOX (oxaliplatin 130 mg/m² IV plus oral S-1) every 3 weeks.

Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel

Eligibility Criteria

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

You may qualify if:

• Fully understands the study and voluntarily provides written informed consent (ICF).
• Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma that is unresectable, advanced, or metastatic.
• HER2-negative and proficient mismatch repair (pMMR).
• Moderate or greater volume of ascites at baseline.
• Peritoneal metastasis confirmed by ascites cytology or laparoscopy.
• Aged 18 to 75 years, regardless of sex.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before the first dose of study treatment.
• Life expectancy of at least 3 months.
• Adequate organ function, as defined by the following criteria:
• Hematologic function, without blood transfusion, granulocyte colony-stimulating factor (G-CSF), or pharmacologic correction within 14 days before screening:
• Neutrophil count ≥1.5 × 10\^9/L;
• Platelet count ≥75 × 10\^9/L;
• Hemoglobin ≥90 g/L.
• Biochemical function, without albumin infusion within 14 days before screening:
• Serum creatinine ≤1.5 × the upper limit of normal (ULN), or creatinine clearance \>50 mL/min;

You may not qualify if:

• HER2-positive tumor, defined as IHC 3+ or IHC 2+ with FISH positivity, or dMMR/MSI-H.
• Previous systemic therapy for unresectable advanced or metastatic GC/GEJ adenocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted provided that treatment was completed at least 6 months before randomization and there was no disease progression.
• Previous immunotherapy, including immune checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; immune checkpoint agonists targeting ICOS, CD40, CD137, GITR, OX40, or other targets; or immune cell therapy.
• Previous intraperitoneal chemotherapy, including hyperthermic intraperitoneal chemotherapy (HIPEC), pressurized intraperitoneal aerosol chemotherapy (PIPAC), or other intraperitoneal chemotherapy.
• Any other active malignancy within the previous 5 years or concurrently with GC/GEJ adenocarcinoma. Patients with cured localized malignancies, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, or breast carcinoma in situ, may be eligible.
• Uncontrolled or moderate or greater pleural effusion or pericardial effusion.
• A bleeding event within 3 months before the first dose requiring blood transfusion, invasive intervention, or hospitalization, or current bleeding symptoms requiring intervention, such as hemoptysis, hematuria, or hematochezia.
• Thrombotic or embolic events within 6 months before initiation of study treatment, including cerebrovascular events such as transient ischemic attack, cerebral hemorrhage, or cerebral infarction, or pulmonary embolism.
• Major surgery within 4 weeks before initiation of study treatment, except diagnostic procedures, or anticipated need for major surgery during the study.
• Inability to swallow tablets, malabsorption syndrome, complete intestinal obstruction, or other conditions that may interfere with gastrointestinal absorption.
• Previous or current central nervous system metastases.
• Active autoimmune disease or a history of autoimmune disease with potential for recurrence, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. Patients with hypothyroidism controlled by hormone replacement therapy may be enrolled. Patients with dermatologic conditions not requiring systemic treatment, such as vitiligo, psoriasis, or alopecia; controlled type 1 diabetes treated with insulin; or childhood asthma that has completely resolved and requires no intervention in adulthood may be enrolled. Patients with asthma requiring medical intervention with bronchodilators are not eligible.
• Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before initiation of study treatment, at a dose \>10 mg/day prednisone or equivalent.
• Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
• Receipt of a live attenuated vaccine within 28 days before initiation of study treatment, or anticipated need for such vaccination during study 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

Location

MeSH Terms

Conditions

Stomach Neoplasms; Ascites

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

Study Officials

• Jieer Ying, Dr

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)