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

NCT07356466 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: FUGES032
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric (Stomach) Cancer

Keywords

Gastric Cancer; HER2-Negative; Objective response rate

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  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

  This study uses the objective response rate (ORR) as the primary efficacy evaluation metric.

  30day

Secondary Outcomes (6)

• Median Overall Survival

  according to the OS

• Progression-Free Survival

  36 months

• Duration of Response

  30day

• Adverse Event

  30 days

• Serious Adverse Event

  30 days

Study Arms (2)

Research Group

EXPERIMENTAL

Participants receive Study Drug Pucotenlimab Combined with Lenvatinib and SOX .

Drug: Pucotenlimab Combined with Lenvatinib

Control Group

OTHER

Oxaliplatin plus S-1 regimen

Drug: Oxaliplatin plus S-1 regimen

Interventions

Pucotenlimab Combined with Lenvatinib DRUG

Pucotenlimab Combined with Lenvatinib

Research Group

Oxaliplatin plus S-1 regimen DRUG

Oxaliplatin plus S-1 regimen

Control Group

Eligibility Criteria

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

You may qualify if:

• \. 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.
• \. 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).
• \. Estimated life expectancy \> 3 months. 7. Adequate major organ function defined as:
• Haematology (obtained ≤ 14 days without transfusion):
• Hb ≥ 80 g/L
• WBC ≥ 3 × 10⁹/L
• ANC ≥ 1.5 × 10⁹/L
• PLT ≥ 100 × 10⁹/L
• Biochemistry:
• Total bilirubin \< 1.5 × upper limit of normal (ULN)
• ALT and AST \< 2.5 × ULN; ALP ≤ 1.5 × ULN
• 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.
• \. No participation in any other interventional clinical trial during the pre-treatment or on-treatment phases of this study.
• \. Voluntary written informed consent obtained; willing and able to comply with study procedures and follow-up.

You may not qualify if:

• Subjects meeting any of the following conditions will be excluded from enrollment:
• Known or suspected hypersensitivity to the investigational drug or any drug of the same class.
• 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.
• Currently receiving treatment in another interventional clinical trial, or any systemic anti-gastric-cancer therapy within 4 weeks prior to the first dose.
• 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.
• 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.
• 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.
• 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.
• Prior allogeneic bone-marrow or solid-organ transplantation.
• Any condition that could impair drug absorption or inability to swallow oral medication.
• Uncontrolled hypertension despite optimal medical management:
• SBP ≥ 150 mmHg or DBP ≥ 100 mmHg on a single antihypertensive, or requirement of ≥ 2 antihypertensive agents.
• Urinalysis showing proteinuria ≥ 2+ and 24-h urinary protein \> 1.0 g.
• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

lenvatinib; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 21, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2030
• Last Updated: January 21, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)