NCT05978193 Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
| NCT ID | NCT05978193 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Chest Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-01-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18; 2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology; 3. ECOG performance status: 0-1 point; 4. No prior anti-tumor treatment; 5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators. Exclusion Criteria: 1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer; 2. Patients who are potentially curable with surgery as assessed by investigators; 3. Pleural metastasis or malignant pleural effusion, pericardial effusion; 4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy; 5. High risk of gastrointestinal bleeding, esophageal fistula, or perforation; 6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9; 7. Unstable cardiac diseases or symptoms; 8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 9. Active autoimmune disease or history of autoimmune disease; 10. Conditions of immunodeficiency or active infection requiring systemic therapy; 11. Pregnant or breastfeeding; 12. 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).
Contact & Investigator
Wen Yu, M.D
PRINCIPAL INVESTIGATOR
Shanghai Chest Hospital
Frequently Asked Questions
Who can join the NCT05978193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05978193 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05978193 currently recruiting?
Yes, NCT05978193 is actively recruiting participants. Contact the research team at yuzhiwen0827@163.com for enrollment information.
Where is the NCT05978193 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT05978193 clinical trial?
NCT05978193 is sponsored by Shanghai Chest Hospital. The principal investigator is Wen Yu, M.D at Shanghai Chest Hospital. The trial plans to enroll 100 participants.