Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (FUGES032)

January 12, 2026 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-Center Randomized Controlled Trial

The purpose of this study is to evaluate the objective response rate (ORR) of Pembrolizumab combined with Lenvatinib and SOX compared with SOX alone in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

At present, for patients with advanced gastric cancer, palliative chemotherapy or the best supportive care is the main treatment approach, but the therapeutic effect is not satisfactory. The median survival time is around 10-16 months, and the survival rate of patients is very low. How to improve the treatment effect of advanced gastric cancer is an urgent problem to be solved. Currently, several studies on immunotherapy combined with chemotherapy for gastric cancer are underway. From the subgroup analyses of a series of studies ，it can be seen that the expression of PDL1 is increased, which provides a basis for the treatment of advanced tumors with immune checkpoint inhibitors. Studies have shown that the combination of Lenvatinib can reduce angiogenesis in mice, reprogram vascular structure, enhance the infiltration of CD8+ T cells, CD8+ TNFα+ T cells and CD8+ IFNγ+ T cells, and decrease the proportion of MDSCs and macrophages. This provides a basis for the combined use of Lenvatinib and immune checkpoint inhibitors in the treatment of advanced tumors. This study adopts a single-center, prospective research method, aiming to explore the clinical effectiveness and safety of Pucotenlimab combined with Lenvatinib and the SOX regimen in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

**Inclusion Criteria** 1. Age 18-75 years (inclusive). 2. Histologically or cytologically confirmed unresectable, locally advanced or metastatic HER2-negative adenocarcinoma of the stomach or gastro-oesophageal junction (GEJ).

3. No prior systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy for advanced disease. Subjects who have received prior (neo)adjuvant chemotherapy and/or radiotherapy are eligible provided the last dose was completed ≥ 6 months before randomisation.

4. At least one measurable lesion per RECIST 1.1 (see Appendix 2). 5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 4).

6. Estimated life expectancy > 3 months. 7. Adequate major organ function defined as:

  1. Haematology (obtained ≤ 14 days without transfusion):

    1. Hb ≥ 80 g/L
    2. WBC ≥ 3 × 10⁹/L
    3. ANC ≥ 1.5 × 10⁹/L
    4. PLT ≥ 100 × 10⁹/L

  2. Biochemistry:

    1. Total bilirubin < 1.5 × upper limit of normal (ULN)
    2. ALT and AST < 2.5 × ULN; ALP ≤ 1.5 × ULN

    3. Serum creatinine ≤ 1 × ULN and calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) 8. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrolment and must use highly effective contraception from screening until 8 weeks after the last dose of study drug. Men must be surgically sterile or agree to use effective contraception during the same period.

      9. No participation in any other interventional clinical trial during the pre-treatment or on-treatment phases of this study.

      10. Voluntary written informed consent obtained; willing and able to comply with study procedures and follow-up.

      Exclusion Criteria:

      Exclusion Criteria

      Subjects meeting any of the following conditions will be excluded from enrollment:

      1. Known or suspected hypersensitivity to the investigational drug or any drug of the same class.
      2. Other malignancies within the past 5 years, except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
      3. Currently receiving treatment in another interventional clinical trial, or any systemic anti-gastric-cancer therapy within 4 weeks prior to the first dose.
      4. Systemic Chinese patent medicines with anti-tumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; local intrapleural use for effusion control is permitted) received within 2 weeks before the first dose.
      5. Prior exposure to: anti-PD-1, anti-PD-L1, anti-PD-L2, or any agent targeting other T-cell co-stimulatory or co-inhibitory pathways (including but not limited to CTLA-4, OX-40, CD137); or prior chemotherapy including S-1.

      6. Live-vaccine administration within 4 weeks before enrollment or planned during the study.

        Note: Inactivated seasonal influenza vaccine by injection is allowed within 4 weeks; intranasal live-attenuated influenza vaccine is prohibited.

      7. Active autoimmune disease requiring systemic therapy (e.g., immunosuppressants, corticosteroids, or disease-modifying agents) within 2 years before the first dose. Replacement therapy (thyroxine, insulin, physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy.
      8. Prior allogeneic bone-marrow or solid-organ transplantation.
      9. Any condition that could impair drug absorption or inability to swallow oral medication.

      10. Uncontrolled hypertension despite optimal medical management:

        • SBP ≥ 150 mmHg or DBP ≥ 100 mmHg on a single antihypertensive, or requirement of ≥ 2 antihypertensive agents.
      11. Urinalysis showing proteinuria ≥ 2+ and 24-h urinary protein > 1.0 g.
      12. Active gastro-duodenal ulcer, ulcerative colitis, or other gastrointestinal disorders with bleeding risk; un-resected tumors with active hemorrhage; or any other condition judged by the investigator to predispose to GI bleeding or perforation.
      13. Significant bleeding tendency within 3 months before enrollment: overt bleeding > 30 mL, hematemesis, melena, hematochezia; hemoptysis (> 5 mL fresh blood within 4 weeks); or thrombo-embolic event (including stroke/TIA) within 12 months.

      14. Clinically significant cardiovascular disease:

        • Acute MI, unstable/severe angina, or CABG within 6 months before enrollment;
        • NYHA class > II congestive heart failure;
        • Ventricular arrhythmia requiring therapy;
        • QTc ≥ 480 ms on baseline ECG.
      15. Active or uncontrolled severe infection (≥ CTCAE grade 2).

      16. Known HIV infection; clinically significant hepatic disorders:

        • Chronic hepatitis B with active replication (HBV DNA > 1 × 10⁴ copies/mL or > 2000 IU/mL);
        • Hepatitis C with detectable HCV RNA (> 1 × 10³ copies/mL);
        • Other hepatitis or cirrhosis.
      17. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
      18. Any condition that, in the opinion of the investigator, would compromise the subject's safety or interfere with study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Research Group
Participants receive Study Drug Pucotenlimab Combined with Lenvatinib and SOX .
Drug: Pucotenlimab Combined with Lenvatinib
Pucotenlimab Combined with Lenvatinib
Other: Control Group
Oxaliplatin plus S-1 regimen
Drug: Oxaliplatin plus S-1 regimen
Oxaliplatin plus S-1 regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 30day
Objective Response Rate (ORR) is defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) based on standardized, objective criteria (e.g., RECIST 1.1).
30day
Objective Response Rate
Time Frame: 30day
This study uses the objective response rate (ORR) as the primary efficacy evaluation metric.
30day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Overall Survival
Time Frame: according to the OS
Median Overall Survival (OS) is defined as the time from the date of diagnosis or initiation of treatment to the point at which 50% of patients have died (or reached the study endpoint event), serving as a key indicator for evaluating treatment efficacy and prognosis in chronic diseases such as cancer.
according to the OS
Progression-Free Survival
Time Frame: 36 months
Progression-Free Survival (PFS) is defined as the time from randomization (or initiation of treatment) to the first documented disease progression (PD) or death from any cause, whichever occurs first
36 months
Adverse Event
Time Frame: 30 days
Adverse Event (AE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event during a specified observation period after initiation of an intervention (drug, device, or procedure); it quantifies the frequency of intervention-related risk.
30 days
Duration of Response
Time Frame: 30day
Duration of Response (DOR) is defined as the time from the first documented complete response (CR) or partial response (PR) until disease progression (PD) or death from any cause, whichever occurs first.
30day
Serious Adverse Event
Time Frame: 30 days
erious Adverse Event (SAE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event meeting seriousness criteria during a specified observation period after initiation of an intervention; it quantifies intervention-related risks with potential for major medical consequences or death.
30 days
Quality of Life (QoL) assessment
Time Frame: 36 months
Quality of Life (QoL) assessment is the systematic collection of patients' subjective experience across multiple domains-including physical function, psychological state, social adaptation, and symptom burden-using validated, standardized patient-reported outcome (PRO) instruments; it quantifies the overall impact of disease and its treatment on patients' daily living and serves as a key endpoint in clinical research and therapeutic decision-making.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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