Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients W… (NCT07356466) | Clinical Trial Compass
By InvitationEarly Phase 1
Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
China100 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕. 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.