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Application of PD-L1/TGF-ßRII bifunctional antibody in advanced esophageal squamous cell carcinoma

Application of PD-L1/TGF-ßRII bifunctional antibody in advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039909
Enrollment
Unknown
Registered
2020-11-14
Start date
2020-11-23
Completion date
Unknown
Last updated
2021-03-22

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

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients who voluntarily participated and signed the informed consent in writing; 2. Patients aged 18-75 years old, regardless of gender; 3. Patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (excluding adenosquamous carcinoma mixed type) confirmed by histopathology; 4. According to recist1.1, patients with at least one measurable lesion; 5. Patients who have not received systemic therapy in the past, or who relapse more than 6 months after the end of (neoadjuvant therapy / radical surgery), including patients with advanced or recurrent non target lesions who progress again after radiotherapy alone. Palliative treatment for local lesions (non target lesions) lasted for more than 4 weeks; 6. The patients with expected survival time >= 3 months; 7. The subjects with ECoG score of 0-1.

Exclusion criteria

Exclusion criteria: 1. Patients who could not tolerate endoscopic biopsy; 2. Patients with anastomotic recurrence after operation; 3. Patients with clear gastrointestinal bleeding concerns (such as local active ulcer lesions, positive stool occult blood); patients with a history of gastrointestinal bleeding within 6 months; patients with a history of gastrointestinal bleeding within 6 months; 4. Patients with known uncontrolled or symptomatic active central nervous system (CNS) metastases.

Design outcomes

Primary

MeasureTime frame
ORR;

Countries

China

Contacts

Public ContactYufeng Cheng

Qilu Hospital of Shandong University

qlcyf@163.com+86 18560081666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026