At a glance
ClinicalIndex Comparison Record- ✓Age at least 18 years
- ✓Metastatic esophageal squamous cell carcinoma stage IVB (M1) confirmed by pathology
- ✓ECOG performance status 0-1
- ✓No prior anti-tumor treatment
- ✕Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types
- ✕Potentially curable with surgery
- ✕Pleural metastasis, malignant pleural effusion, or pericardial effusion
- ✕Prior anti-tumor therapy (surgery, radiotherapy, chemotherapy, or immunotherapy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating LDRT+CFRT, Immunotherapy, and 1 other intervention for Esophageal Squamous Cell Carcinoma and 2 related conditions. Currently recruiting, targeting 100 participants across 2 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles ; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle
PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years
Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles