Clinical trial NCT06232083: Application of PLDR External Irradiation Combined With Immune Checkpoint Inhibitors in Recurrent Cervical Cancer
Official title: A Single Arm, Exploratory Phase I Clinical Study of PLDR External Irradiation Combined With PD-1/PD-L1 Inhibitors in the Treatment of Recurrent Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cervical Squamous Cell Carcinoma
Radiotherapy
Immunotherapy
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-30
Enrollment: 33
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: PFS
timeFrame: 6 month post PLDR external irradiation
Secondary outcomes:
measure: Toxic side effects
timeFrame: 6 month post PLDR external irradiation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China
state: British Columbia
Study officials:
References: