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Trial Title:
PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC
NCT ID:
NCT06186609
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Esophageal Squamous Cell Carcinoma
Immune Checkpoint Inhibitors
Conditions: Keywords:
Elderly patient
Esophageal Cancer
PD-1 inhibitor
Radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 inhibitor 200mg per three to four weeks, for one year
Description:
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.
Arm group label:
Experiment Arm
Other name:
radiotherapy
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 their ability to tolerate concurrent chemoradiotherapy in comparison
to nonelderly patients because of medical comorbidities and reduced functional reserve of
organs. Immune checkpoint inhibitors, including PD-1 inhibitor, have been used in a large
number of clinical studies on esophageal cancer and have achieved certain results. PD-1
inhibitor combined with radiotherapy may be a new strategy for elderly patients with
esophageal cancer. This study aims to explore the efficacy and safety of PD-1 inhibitor
combined with radiotherapy in the treatment of elderly patients with esophageal cancer.
PD-1 inhibitor was delivered 200mg once before radiotherapy and 200mg every 3-4 weeks
after radiotherapy for one year.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients aged 70 years or above
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:
1. Esophageal bronchial fistula or esophageal mediastinal fistula
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.
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226001
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Weiwei
Phone:
18930174528
Email:
yww333@126.com
Contact backup:
Last name:
Song Haotian
Phone:
19827031325
Email:
sht980212@163.com
Start date:
July 1, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06186609
