Retlirafusp Alfa Combined With Chemoradiotherapy in Unresectable ESCC
ConditionEsophageal Squamous Cell Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital
About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.
Eligibility criteria
Qualifiers
Voluntarily sign the written informed consent form and agree to participate in this study;
Pathologically confirmed esophageal squamous cell carcinoma;
Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition);
Aged 18-75 years, male or female;
Disqualifiers
Any prior or ongoing radiotherapy, chemotherapy, or other anti-tumor agents for malignancy;
Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at a dose > 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids, and adrenal hormone replacement at doses > 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease;
Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug;
Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;
Trial design
Treatments tested in this trial
- Induction chemo-immunotherapy
- Concurrent chemoradiotherapy (cCRT)
- maintenance immunotherapy
Treatment groups
68 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov