Status:
RECRUITING
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the...
Detailed Description
In metastatic esophageal cancer, radiotherapy is often administered for palliative purposes to alleviate the symptom of dysphagia. Recent studies have shown that the combination of radiotherapy and im...
Eligibility Criteria
Inclusion
- Age ≥18;
- Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
- ECOG performance status: 0-1 point;
- No prior anti-tumor treatment;
- Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.
Exclusion
- Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
- Patients who are potentially curable with surgery as assessed by investigators;
- Pleural metastasis or malignant pleural effusion, pericardial effusion;
- Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
- Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
- Unstable cardiac diseases or symptoms;
- History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
- Active autoimmune disease or history of autoimmune disease;
- Conditions of immunodeficiency or active infection requiring systemic therapy;
- Pregnant or breastfeeding;
- Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05978193
Start Date
January 1 2023
End Date
January 1 2027
Last Update
August 7 2023
Active Locations (2)
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1
Shanghai Ruijin Hospital
Shanghai, China, 200020
2
Shanghai Chest Hospital
Shanghai, China, 200030