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Large, Collaborative, Real-world, Observational, Cohort study of PD-1 inhibitors in the treatment of Esophageal Squamous cell Carcinoma

Large, Collaborative, Real-world, Observational, Cohort study of PD-1 inhibitors in the treatment of Esophageal Squamous cell Carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078657
Enrollment
Unknown
Registered
2023-12-14
Start date
2023-12-30
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Esophageal cancer

Interventions

Retrospective cohort (PD-1 inhibitors alone or in combination therapy):NA
Prospective cohort 1 (PD-1 inhibitor monotherapy or combined neoadjuvant/conversion therapy):NA
Prospective cohort 2 (PD-1 inhibitor monotherapy or combined adjuvant therapy):NA
Prospective cohort 3 (PD-1 inhibitors alone or in combination with first-line therapy):NA
Prospective cohort 4 (PD-1 inhibitors alone or in combination with second-line or above treatment:NA

Sponsors

Sichuan Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. pathologically or cytologically confirmed esophageal squamous cell carcinoma; 2. received PD-1 inhibitor therapy; 3. the subject voluntarily joined this study and signed an informed consent form

Exclusion criteria

Exclusion criteria: 1. a history of malignancy other than esophageal cancer within 5 years before enrollment, but the risk of metastasis or death is negligible (e.g., expected 5-year overall survival rate > 90%), except for malignancies that are expected to recover after treatment, such as appropriately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery; 2. known or suspected hypersensitivity to PD-1 inhibitors; 3. this study is a real-world study without other special exclusion criteria

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Pathologic Complete Response Rate in Cohort 1;Disease-free survival in Cohort 2;Progression Free Survival in Cohort 3/4;Overall Survival;Safty;Patient quality of life and related scales;

Countries

China

Contacts

Public ContactXuefeng Leng

Sichuan Cancer Hospital & Institute

doc.leng@uestc.edu.cn+86 187 0287 0755

Outcome results

None listed

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