Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastro… (NCT07072351) | Clinical Trial Compass
RecruitingPhase 1/2
Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma
China88 participantsStarted 2025-09-15
Plain-language summary
The purpose of this study is to investigate the safety and efficacy of conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable GEJA.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically and/or cytologically confirmed diagnosis of locally advanced gastroesophageal junction adenocarcinoma (GEJA), Siewert type I-III, with staging of cT3-4, any N, M0 or cT2 N+, M0, according to the AJCC 8th edition.
✓. Resectable locally advanced disease as determined by multidisciplinary team (MDT) assessment.
✓. Age ≥18 years, regardless of sex.
✓. ECOG performance status of 0 or 1.
✓. Estimated life expectancy of ≥3 months.
✓. No prior anti-tumor therapy.
✓. At least one measurable lesion per RECIST v1.1, defined as:
✓. Adequate organ function within 14 days prior to treatment, as defined below (Note: No RBC or platelet transfusion or use of G-CSF within 14 days prior to hematology testing):
Exclusion criteria
✕. Diagnosed as mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) by immunohistochemistry or gene testing.
✕. Evidence of peritoneal or multi-organ metastatic disease, as confirmed by chest and abdominal CT, bone scan, or MRI (in cases with suspected osseous lesions).
✕. History of or concurrent other malignancies within the past 5 years, excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
What they're measuring
1
Safety and tolerability in Phase Ib
Timeframe: within 3 months after the HFRT
2
ORR rate in Phase II
Timeframe: approximately 4 weeks after the resection of primary lesion
. Known allergy to any component of the investigational drugs, history of severe hypersensitivity, or any contraindication to study drugs.
✕. Clinically significant upper gastrointestinal bleeding within 30 days prior to enrollment or randomization.
✕. History of congenital pulmonary fibrosis, drug-induced pneumonitis, active pulmonary tuberculosis, or CT-confirmed active pneumonia; interstitial lung disease requiring steroid treatment.
✕. Active autoimmune or inflammatory diseases requiring immunosuppressive therapy within 2 years prior to treatment, including but not limited to:
✕. History of immunodeficiency, HIV infection (positive HIV 1/2 antibodies), congenital or acquired immunodeficiency disorders, or history of organ transplantation.