A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
Overview
- Phase
- Phase 2
- Intervention
- chemotherapy combined with PD-1 inhibitors
- Conditions
- Esophageal Squamous Cell Carcinomas
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Overall Survival Rate
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.
Investigators
Jun Liu
associate professor
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged ≥ 18 years at the time of screening.
- •Histologically confirmed squamous cell carcinoma;
- •Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
- •Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
- •Able to eat a semi-liquid diet;
- •Less than 20% weight loss within 6 months;
- •Adequate hepatic function, renal function, hematologic function and coagulation function;
- •Documented informed consent.
Exclusion Criteria
- •Distant metastasis;
- •Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
- •Prior thoracic irradiation, chemotherapy, or lobectomy
- •Known diseases or conditions that are contraindicated for radiotherapy or surgery;
- •Allergy to the research medications;
- •Pregnant women or women preparing for pregnancy;
- •Diagnosis of autoimmune disease or history of chronic autoimmune disease
- •Absence of informed consent because of psychological, family, social and other factors;
- •Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).
Arms & Interventions
experimental arm
Induction Therapy: Two cycles of induction chemotherapy (nab-paclitaxel 200 mg/m², day 1; carboplatin AUC 5, day 1) combined with a PD-1 inhibitor (200 mg, day 1) every 3 weeks. Concurrent Therapy: Followed by concurrent chemoradiotherapy (CCRT). Maintenance Therapy: Patients without progressive disease (PD) will receive maintenance immunotherapy with a PD-1 inhibitor (200 mg every 3 weeks) for up to 1 year.
Intervention: chemotherapy combined with PD-1 inhibitors
Outcomes
Primary Outcomes
Overall Survival Rate
Time Frame: 2 years after last patient enrolled
Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment
Secondary Outcomes
- Treatment related complications(During the procedure)
- progression-free Survival (PFS)(2 years after last patient enrolled)