Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

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

Qualifiers

Age ≥18;

Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;

ECOG performance status: 0-1 point;

No prior anti-tumor treatment;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • LDRT+CFRT
  • Immunotherapy
  • Chemotherapy

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators