To hear about similar clinical trials, please enter your email below
Trial Title:
Application of PLDR External Irradiation Combined With Immune Checkpoint Inhibitors in Recurrent Cervical Cancer
NCT ID:
NCT06232083
Condition:
Cervical Squamous Cell Carcinoma
Radiotherapy
Immunotherapy
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 1/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:
Radiation
Intervention name:
PLDR+Cardunizumab
Description:
Application of PLDR external irradiation combined with Cardunizumab in recurrent cervical
cancer
Arm group label:
PLDR+αPD-1
Summary:
At present, the treatment methods for recurrent cervical cancer are very limited. The
immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent cervical
cancer, but the clinical response rate is insufficient. Pulse low-dose rate radiotherapy
(PLDR) is a new technology in recent years, which uses continuous pulse low-dose rate
irradiation to induce hypersensitivity in tumors, and its clinical safety has been
verified. Compared to conventional radiotherapy, PLDR has advantages in protecting the
lymphatic system and relieving the immune barrier, but it is still unclear whether it can
improve the efficacy of ICB. This project aims to combine PLDR with ICB to explore new
strategies for recurrent cervical cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily participate and sign an informed consent form in writing;
2. Age 20-70 years old, ECOG score 0-2 points;
3. Newly diagnosed metastatic cervical squamous cell carcinoma or adenocarcinoma
patients who have been assessed as unsuitable or have refused chemotherapy;
4. Cervical squamous cell carcinoma or adenocarcinoma patients who experience
recurrence and metastasis after regular treatment (local recurrence should be ruled
out by surgery);
5. Laboratory examination: White blood cells ≥ 3.0 × 109/L; Hemoglobin ≥ 90 g/L; Number
of neutrophils ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; The liver and kidney
function, thyroid function, and other indicators are all within the range of 1.25
times the upper normal limit value; Normal coagulation function; The indicators of
cardiac troponin and myocardial enzyme spectrum are normal, and the
electrocardiogram is normal.
6. The expected survival period is more than 6 months and the follow-up conditions are
met;
7. Patients are able to coordinate positioning and receive long-term treatment;
8. Previous radiation therapy information can be obtained, such as the total dose of
the target area, segmentation mode, dose distribution, and normal tissue dose;
9. For patients with recurrent cervical cancer, the initial irradiation dose (external
irradiation+close range irradiation) is safe and well tolerated after EQD2
calculation.
Exclusion Criteria:
1. Elderly patients (>70 years old);
2. ECOG score ≥ 3 points;
3. The pathological type is adenocarcinoma or other rare cervical cancer;
4. Those diagnosed with severe liver and lung metastasis, malignant pleural and ascitic
fluid, complete intestinal obstruction, and other extremely poor expected survival
through imaging;
5. The patient is accompanied by severe ureteral stenosis, hematuria, or bladder
vaginal fistula;
6. Has a history of severe allergies or specific physical conditions;
7. Diagnosed as immunodeficiency or presence of active hepatitis B and C, active
tuberculosis;
8. Patients with missing initial external irradiation information and inability to
estimate dose;
9. Patients who have not signed informed consent or are unwilling to undergo follow-up;
10. Patients with a disease-free survival time of less than 3 months or who have
received routine radiation within the past six months.
Gender:
Female
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Recruiting
Contact:
Last name:
Peijie Zhou, doctor
Phone:
+8618356148326
Email:
zhpejie@ustc.edu.cn
Start date:
February 1, 2024
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06232083
