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A retrospective real-world study evaluating the safety and efficacy of neoadjuvant PD-1 blockade plus half-dose chemotherapy in patients aged 70 years and older with esophageal squamous cell carcinoma

A retrospective real-world study evaluating the safety and efficacy of neoadjuvant PD-1 blockade plus half-dose chemotherapy in patients aged 70 years and older with esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100092
Enrollment
Unknown
Registered
2025-04-02
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-04-07

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

Reduced-dose Chemotherapy Combined with Immunotherapy Group:None

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
70 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient should have histologically proven esophageal squamous cell carcinoma and the lesion should be located in the thoracic esophagus; 2. Patients with clinical stage cT1b-cT2 with lymph node metastasis and without distant metastasis, cT3-cT4a with or without lymph node metastasis and without distant metastasis; 3. The patient should be >=70 years old with ECOG PS score of 0-1; 4. Normal function of major organ, including (a) hematology: neutrophil count >= 1.5 × 10^9/L, leukocyte count >= 3 × 10^9/L, platelet count >= 100 ×10^9/L; (b) blood biochemistry: total bilirubin =30 ml/min; 5. PET-CT or CT of neck, chest and upper abdomen; bone scan, brain CT/MR Imaging data of patients before and after neoadjuvant therapy should be complete; with clear staging and exclude distant metastasis; 6. Complete imaging and pathological data should be available.

Exclusion criteria

Exclusion criteria: 1. Receiving treatment options other than immunotherapy and chemotherapy, such as targeted therapy and radiation therapy; 2. Lack of imaging and pathological data; 3. Combine other diseases that affect treatment decisions.

Design outcomes

Primary

MeasureTime frame
the incidence rate of treatment-related adverse events;

Secondary

MeasureTime frame
objective response rate;pathological complete response rate;progression-free survival;overall survival;disease control rate;

Countries

China

Contacts

Public ContactChao Cheng

The First Affiliated Hospital of Sun Yat-Sen University

chengch3@mail.sysu.edu.cn+86 137 1076 3975

Outcome results

None listed

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