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Sintilimab with or without Chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma: a randomised controlled phase II trial

Sintilimab with or without Chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma: a randomised controlled phase II trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040196
Enrollment
Unknown
Registered
2020-11-25
Start date
2020-11-25
Completion date
Unknown
Last updated
2021-01-18

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

Treatment group:Sintilimab with Chemotherapy

Sponsors

Affiliated Cancer Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged older than 18 years; 2. Had histological or cytological diagnosis of oesophageal squamous cell carcinoma; 3. Patients had advanced or metastatic oesophageal squamous cell carcinoma who were intolerant to first-line chemotherapy; 4. Had at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECISTVersion 1.1); 5. Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Had adequate haematological, hepatic, and renal function.

Exclusion criteria

Exclusion criteria: 1. Not receive Docetaxel/Paclitaxel/Irinotecan; 2. Previou therapies with palliative radiotherapy within 2 weeks befo the start of study treatment; 3. A history of anti-PD-1 or anti-PD-L1 therapy; 4. Had diagnosis of other malignant tumors(except cured basal cell carcinoma of skin and squamous cell carcinoma of skin and squamous cell carcinoma of skin or cervical carcinoma in situ, or breast cancer in situ); 5. CNS metastases; 6. A history of or having active auto immune disease; 7. Previous therapies with corticosteroids or other immunosuppressants within 2 weeks before initiation of study treatment; 8. Had interstitial lung disease or active non-infectious pneumonia; 9. HIV infection.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Countries

China

Contacts

Public ContactYi Jiang

Affiliated Cancer Hospital of Shantou University Medical College

jiangzy_123@sina.com+86 13553389578

Outcome results

None listed

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