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Exploratory study of PD-L1/TGF-ßRII bifunctional antibody combined with radiotherapy as neoadjuvant therapy for esophageal squamous cell carcinoma

Exploratory study of PD-L1/TGF-ßRII bifunctional antibody combined with radiotherapy as neoadjuvant therapy for esophageal squamous cell carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041562
Enrollment
Unknown
Registered
2020-12-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

experimental group:PD-L1/TGF-ßRII bifunctional antibody

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 73 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-73 years old, male or female; 2.Histopathology diagnosed as resectable thoracic esophageal squamous cell carcinoma (cT1b-cT2 N+ or cT3-cT4a, any N); 3.There is at least one measurable lesion (according to the requirements of RECIST Version 1.1, the spiral CT scan of the measurable esophageal lesion has a long diameter >= 10 mm, a CT scan of a lymph node lesion with a short diameter >= 15 mm, and a scan thickness not greater than 5 mm; patients have not received local treatment), and measurable lesion is suitable for surgery; 4.The expected survival time was >= 6 months;5. ECOG score 0-1.

Exclusion criteria

Exclusion criteria: 1.The patient is unable to tolerate digestive endoscopic biopsy; 2.The patient has clear gastrointestinal bleeding concern (such as local active ulcer lesions, positive stool occult blood); history of gastrointestinal bleeding within 6 months; 3.The patient has central nervous system metastasis.

Design outcomes

Primary

MeasureTime frame
Pathologic Complete Response;

Countries

China

Contacts

Public ContactLi Baosheng

Shandong Cancer Hospital

bsli@sdfmu.edu.cn+86 13954168847

Outcome results

None listed

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