Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor
Tang-Du Hospital
Study ID
NCT07709767
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Retlirafusp Alfa — DRUG
    Retlirafusp alfa 1800 mg will be administered by intravenous infusion on Day 1 of each 21-day cycle. When administered with chemotherapy, retlirafusp alfa will be given first, followed by chemotherapy after an interval of at least 30 minutes.
  • Oxaliplatin — DRUG
    Oxaliplatin 130 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
  • Capecitabine — DRUG
    Capecitabine 1000 mg/m\^2 will be administered orally twice daily on Days 1-14 of each 21-day cycle. Interventi
  • Radical Surgery — PROCEDURE
    Participants who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery 4 to 6 weeks after the last dose of preoperative treatment.

Study Details

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.

Key Dates

First listed
Jul 17, 2026
Start date
Aug 30, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2028
Completion
Aug 30, 2032

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Retlirafusp Alfa Plus CAPOX

Primary Outcome Measure

R0 Resection Rate [ Time Frame: From treatment initiation to pathological assessment after radical surgery, up to approximately 28 weeks ]

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