NCT05978193RecruitingPhase 2
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Jul 2023
- Start date
- 1 Jan 2023
- Primary completion date
- Jan 2027
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05978193
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Jan 2023 to the primary completion date, Jan 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are potentially curable with surgery as assessed by investigators;
- Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
Other illness
- Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
- Pleural metastasis or malignant pleural effusion, pericardial effusion;
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
- 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;
- 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).
Other
- Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
- Pregnant or breastfeeding;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Ruijin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.