Status:
RECRUITING
PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC
Lead Sponsor:
Affiliated Hospital of Nantong University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
Concurrent chemoradiotherapy is now considered to be the standard treatment modality for esophageal cancer patients who are medically unfit for surgery. However, elderly patients have limitations in t...
Detailed Description
Study Design Primary Purpose: To investigate the safety and efficacy of PD-1 inhibitor combined with radiotherapy for elderly patients with esophageal squamous cell carcinoma. Study Phase: Phase II I...
Eligibility Criteria
Inclusion
- Patients aged 70 years or above
- Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy
- Stage II-IVa according to the AJCC TNM staging system
- Estimated survival time ≥ 3 months
- Karnofsky performance score ≥70
- Normal blood routine, liver and kidney function less than 2 times of the normal upper limit
- Without mental disorders, cooperate with treatment and follow-up
- Have fully understood this study and voluntarily signed the informed consent
Exclusion
- Esophageal bronchial fistula or esophageal mediastinal fistula
- Patients who have participated in other clinical trials before this treatment
- Severe heart, liver and/or kidney dysfunction
- Serious infectious diseases
- EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy
- Severe autoimmune disease
- Relapse disease or distant metastasis
- Combined with other malignant tumors.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06186609
Start Date
July 1 2023
End Date
June 30 2026
Last Update
January 2 2024
Active Locations (1)
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1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001