AzTrials
AzTrials

Gastric Cancer (GC)NCT07855757

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

A study testing Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel in people with Gastric Cancer (GC) and Peritoneal Metastases From Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChina
Study dates
1 Jun 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 26Show fewer
  • 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;
  • Total serum bilirubin ≤1.5 × ULN; for patients with Gilbert syndrome, total bilirubin ≤3 × ULN is permitted;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; for patients with liver metastases, AST and ALT ≤5 × ULN.
  • Coagulation function:
  • International normalized ratio (INR) ≤2.3, or prothrombin time (PT) prolonged by ≤6 seconds above the normal control range;
  • Urine protein <2+; if urine protein is ≥2+, a 24-hour urine protein test may be performed, and patients with 24-hour urinary protein <1.0 g may be enrolled.
  • Cardiac function:
  • New York Heart Association (NYHA) functional class <III;
  • Left ventricular ejection fraction ≥50%.
  • For patients with active hepatitis B virus (HBV) infection, HBV DNA must be <500 IU/mL (or <2,500 copies/mL if the study center reports HBV DNA only in copies/mL), and the patient must be willing to receive continuous antiviral therapy throughout the study. Patients with positive hepatitis C virus (HCV) RNA must receive antiviral therapy according to local standard treatment guidelines, with liver function abnormalities no greater than CTCAE Grade 1.
  • Women of childbearing potential must have a negative serum pregnancy test within 28 days before enrollment and agree to use effective contraception during study treatment and for 60 days after the last dose. Women of childbearing potential are defined as sexually mature women who: (1) have not undergone hysterectomy or bilateral oophorectomy, and (2) have not experienced natural amenorrhea for at least 24 consecutive months. Amenorrhea following cancer treatment does not exclude childbearing potential. Female partners of male participants who are of childbearing potential must also comply with the above contraceptive requirements.
  • Patients must have adequate nutritional status, defined as body mass index (BMI) ≥18 kg/m2, body weight ≥40 kg, and serum albumin ≥3.0 g/dL.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.
  • Receipt of cytotoxic antitumor therapy within 2 weeks before the first dose; or biological therapy, such as monoclonal antibodies, immunotherapy such as interleukins, interferons, or thymosin, or other investigational drugs within 4 weeks before the first dose.
  • Uncontrolled concomitant disease, including severe hypertension, decompensated cirrhosis, nephrotic syndrome, angina pectoris, severe arrhythmia, interstitial lung disease, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, severe bleeding tendency, or coagulation disorders.
  • Toxicities from previous antitumor therapy that have not recovered to CTCAE Grade 0-1, except for:
  • Alopecia;
  • Pigmentation;
  • Peripheral neurotoxicity recovered to <CTCAE Grade 2;
  • Late toxicity caused by radiotherapy that, in the investigator's judgment, is not expected to recover.
  • Active tuberculosis (TB) requiring antituberculosis treatment.
  • Active hepatitis B or hepatitis C, defined as HBsAg positivity with detectable HBV DNA, or HBcAb positivity.
  • Pregnant or breastfeeding women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

Other trials in China

About this study

Official title: An Exploratory Study of Retlirafusp Alfa in Combination With SOX and Intraperitoneal Nab-Paclitaxel as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With Malignant Ascites

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.

Read the detailed description

Peritoneal metastasis with malignant ascites is a common manifestation of advanced gastric cancer and is associated with poor prognosis. This is an open-label, single-arm exploratory clinical study conducted at Zhejiang Cancer Hospital, which plans to enroll 5 patients with previously untreated unresectable advanced or metastatic gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with peritoneal metastasis and malignant ascites. Patients will receive retlirafusp alfa in combination with SOX chemotherapy and intraperitoneal nab-paclitaxel as first-line treatment.

The study aims to evaluate the efficacy and safety of this treatment strategy. To explore potential biomarkers associated with treatment response, peripheral blood, ascites, fecal samples, and tumor tissues will be collected at protocol-specified time points for analyses including single-cell transcriptomic sequencing, immune factor and metabolite profiling, fecal metagenomic sequencing, and immunohistochemistry.

Being tested
Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel
Keywords
Malignant ascites, Gastric Cancer, Peritoneal Metastases
Medical subject headings
Stomach Neoplasms, Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retlirafusp Alfa + SOX + Intraperitoneal Nab-PaclitaxelDrug

    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.

Study groups in NCT07855757
Study groupRoleWhat they receive
Retlirafusp Alfa + SOX + Intraperitoneal Nab-PaclitaxelExperimentalPatients 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.
Receives: Drug: Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS is calculated from diagnosis to death or last follow-up time

    Measured: 1 year

  2. Progress free survival (PFS)

    PFS is defined as the time from the date of treatment to the first date of disease

    Measured: 1 year

  3. 12 months os rate

    The definition of 12-months OS rate is the percentage of patients who had NOT has an event before or at 12 months

    Measured: 1 year

  4. Obiective response rate of Solid tumor lesion (if exists)

    Number of participants with partial response or complete response treating by anloitnib according to RESIST criteria v1.1

    Measured: 1 year

  5. Safety assessment

    Number and percentage of participants with Adverse Events (any Grade and Grade 3/4)

    Measured: 1 year

  6. Dynamics of Peripheral Blood Biomarkers

    Changes in blood-based biomarker levels will be measured. Peripheral blood samples will be used for: 1) Immunophenotyping: The frequency of key immune cell subsets (e.g., CD4+/CD8+ T cells) in PBMCs will be analyzed by flow cytometry and single-cell transcriptome sequencing. 2) Plasma Multi-omics: Proteins and metabolites will be profiled using proteomics and metabolomics platforms, respectively. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.

    Measured: Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months]

  7. Biomarkers in Tumor Tissue

    tumor tissue samples will be used for: 1) Immunophenotyping: The frequency of multiple cell subsets in fresh tumors will be analyzed by single-cell transcriptome sequencing. 2) Paraffin sections: used for immunohistochemistry and immunofluorescence. Data will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.3）Single-cell transcriptome sequencing

    Measured: Baseline; prior to Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months

  8. Dynamics of Ascites Biomarkers

    Changes in ascites-based biomarker levels will be measured. Ascites samples will be used for: 1) Cell clustering: The frequency of multiple cell subsets in ascites will be analyzed by flow cytometry and single-cell transcriptome sequencing. 2) ascites multi-omics: Proteins and metabolites of ascites supernatant will be profiled using ELISA, proteomics, metabolomics platforms, and etc. Metrics will include the mean change from baseline at each timepoint and the correlation of these changes with clinical response.

    Measured: Baseline; prior to Cycle 2 or Cycle 3 of treatment; and at documented disease progression, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start1 Jun 2026
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07855757
Sponsor's protocol ID
IRB-2026-675
Status last verified
Aug 2026
First submitted
28 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Retlirafusp Alfa + SOX + Intraperitoneal Nab-Paclitaxel in people with Gastric Cancer (GC) and Peritoneal Metastases From Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ascites objective response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07855757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in