Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camr… (NCT07530094) | Clinical Trial Compass
RecruitingPhase 2
Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
China98 participantsStarted 2025-12-01
Plain-language summary
This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patient or their legal representative is able to sign the written informed consent form and understands and agrees to comply with the study requirements;
✓. Age ≥ 18 years and \< 75 years at the time of signing the informed consent form, regardless of gender;
✓. Histologically confirmed esophageal squamous cell carcinoma, confirmed by imaging examinations such as CT, MRI, or PET-CT as locally advanced unresectable ESCC (medically unsuitable for surgery or refusal of surgical intervention), and suitable for cCRT, including: stages II-IVa and certain cases of stage IVb (involving only supraclavicular lymph node metastasis) (AJCC version 8 ) meeting the criteria;
✓. Estimated life expectancy of at least 6 months;
✓. ECOG performance status score of 0-2;
✓. Presence of measurable and/or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
✓. No prior systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biological therapy, local therapy, or other investigational treatments);
✓. Adequate organ function, as indicated by laboratory test results obtained within 14 days prior to enrollment:
Exclusion criteria
✕. History of other malignancies;
✕. History of fistula caused by primary tumor infiltration;
What they're measuring
1
1-year Progression- Free Survival
Timeframe: from study enrollment to tumor progression (in any aspect) or death from any cause within 1 year.
. Patients at high risk of esophageal fistula or with signs of esophageal perforation;
✕. History of esophageal cancer surgery;
✕. Poor nutritional status, with BMI less than 18.5 kg/m², or PG-SGA score ≥ 9;
✕. Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to randomization);
✕. Known intolerance or resistance to the chemotherapy regimen specified in the study protocol;
✕. Prior receipt of any other anti-tumor therapy for ESCC (e.g., therapies targeting PD-1, PD-L1, PD-L2, or other tumor immunotherapies, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);