Pucotenlimab Combined With Chemotherapy as Perioperative Treatment for Locally Advanced Gastroeso… (NCT07092449) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pucotenlimab Combined With Chemotherapy as Perioperative Treatment for Locally Advanced Gastroesophageal Junction Carcinoma
30 participantsStarted 2025-08-01
Plain-language summary
This study is a prospective, multicenter, single-arm clinical trial.
The study intends to enroll patients with pathologically or cytologically confirmed resectable locally advanced gastroesophageal junction tumors (cT2N+M0 and cT3-4bNxM0) who have not received prior systemic therapy. After signing the informed consent and being screened to meet the inclusion and exclusion criteria, patients will receive 3 cycles of Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin). Preoperative imaging evaluations will be performed 3 to 6 weeks after the final dose administration to assess the efficacy of neoadjuvant therapy and the feasibility of radical resection. Efficacy evaluation will be performed after radical surgery for locally advanced gastroesophageal junction tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Informed Consent Provide written informed consent for the clinical study and biobank before any study-related procedures.
✓. Age and Gender Male or female patients aged 18 to 75 years.
✓. Prior Treatment History No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
✓. Surgical Eligibility Agree to receive radical surgery and have no surgical contraindications as judged by surgeons.
✓. Target Lesion Assessment At least one lesion (untreated with radiotherapy) meets RECIST 1.1 target lesion (TL) criteria.
✓. Performance Status ECOG score of 0-1.
✓. Life Expectancy Expected survival ≥ 3 months.
Exclusion criteria
✕. Diagnosed with malignant diseases other than gastroesophageal junction tumors within 5 years before the first administration (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ after radical resection);
What they're measuring
1
pCR
Timeframe: From enrollment to the end of treatment at 2 weeks
✕. Known endoscopic evidence of active bleeding in the lesion;
✕. Known evidence of distant metastasis;
✕. Currently participating in therapeutic interventions of an interventional clinical study, or having received other drug therapies for malignant gastroesophageal junction tumors within 4 weeks before the first administration;
✕. Having previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.), or chemotherapy (including but not limited to S-1);
✕. Having received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally to control pleural effusion) within 2 weeks before the first administration;
✕. Having had active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment;
✕. Receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent drugs) is allowed;