PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC
NCT ID: NCT06186609
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
68 participants
INTERVENTIONAL
2023-07-01
2026-06-30
Brief Summary
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Detailed Description
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Study Phase: Phase II Intervention Model: PD-1 inhibitor combined with radiotherapy Number of Arms: One Masking: No Allocation: 68 patients for one single group Enrollment: 68 patients Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Esophageal squamous cell carcinoma with stage II to IVA, 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS ≥ 70, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.
Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Severe autoimmune disease, 4. Joining other clinical trial prior this study.
Intervention: PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year. Radiotherapy:56-60Gy/28-30 fraction.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experiment Arm
PD-1 inhibitor combined with radiotherapy
PD-1 inhibitor 200mg per three to four weeks, for one year
PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.
Radiotherapy:56-60Gy/28-30 fraction.
Interventions
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PD-1 inhibitor 200mg per three to four weeks, for one year
PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.
Radiotherapy:56-60Gy/28-30 fraction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy
3. Stage II-IVa according to the AJCC TNM staging system
4. Estimated survival time ≥ 3 months
5. Karnofsky performance score ≥70
6. Normal blood routine, liver and kidney function less than 2 times of the normal upper limit
7. Without mental disorders, cooperate with treatment and follow-up
8. Have fully understood this study and voluntarily signed the informed consent
Exclusion Criteria
2. Patients who have participated in other clinical trials before this treatment
3. Severe heart, liver and/or kidney dysfunction
4. Serious infectious diseases
5. EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy
6. Severe autoimmune disease
7. Relapse disease or distant metastasis
8. Combined with other malignant tumors.
70 Years
ALL
No
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Weiwei Yu
professor
Principal Investigators
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Yu Weiwei
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Affiliated Hospital of Nantong University
Locations
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Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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02121998
Identifier Type: -
Identifier Source: org_study_id
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