Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNing Jiang, M.D./Ph.D.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

History of other malignancies;

History of fistula caused by primary tumor infiltration;

Patients at high risk of esophageal fistula or with signs of esophageal perforation;

History of esophageal cancer surgery;

Trial design

Treatments tested in this trial

  • Camrelizumab

Treatment groups

98 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ning Jiang, M.D./Ph.D.

Lead sponsor

Jiangsu Cancer Institute & Hospital

Sponsor institution