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Exploring the Optimal Scheduling of Combined Radiotherapy and Immunotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Retrospective, Real-World Study

Exploring the Optimal Scheduling of Combined Radiotherapy and Immunotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Retrospective, Real-World Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111871
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

ESCC:None

Sponsors

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1: Aged between 18 and 85 years. 2: Histopathologically confirmed diagnosis of esophageal squamous cell carcinoma. 3: Unresectable locally advanced disease (including technically unresectable tumors, patients with surgical contraindications, or those refusing surgery) classified as cT1b-4bN0M0 or cT1b-4bN+M0 ( AJCC 8th edition); or unresectable advanced disease with supraclavicular lymph node metastasis classified as cTxNxM1 ( AJCC 8th edition). 4: At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). 5: Karnofsky Performance Status (KPS) score >= 60. 6: Patients must have received first-line immunochemotherapy; radiotherapy is permitted, which may be administered before, during, or after immunotherapy.

Exclusion criteria

Exclusion criteria: 1: Presence of distant metastasis to solid organs or non-regional lymph nodes (excluding supraclavicular lymph node). 2: History of a second primary cancer or previous malignancy (except for radically treated papillary thyroid carcinoma, Stage I seminoma, or carcinoma in situ of the cervix). 3: Receipt of surgical resection of esophageal carcinoma. 4: Salvage immunotherapy for esophageal carcinoma that recurred after radiotherapy; or initiation of consolidative immunotherapy more than 42 days after radiotherapy completion. 5: Severe esophageal fistula or gastrointestinal hemorrhage at diagnosis, with persistent fistula or refractory bleeding despite adequate supportive treatment. 6: First-line treatment containing targeted therapeutic agents, including recombinant human endostatin injection, anlotinib, nimotuzumab injection, apatinib (except when used for treating telangiectasia), etc. 7: First-line treatment consisting of chemotherapy only, without concurrent immunotherapy or radiotherapy. 8: No radiation, chemotherapy, or immunotherapy received within 3 months after pathological diagnosis. 9: Absence of documented baseline TNM staging, or absence of baseline chest CT scan. 10: Enrollment in a double-blind clinical trial without unblinding or lack of available treatment information.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Adverse event;Progression-free survival;

Countries

China

Contacts

Public ContactDong Qian

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

liuhq_oncology@163.com+86 182 0226 9589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026