Application of PLDR External Irradiation Combined With Immune Checkpoint Inhibitors in Recurrent Cervical Cancer

Immunotherapy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232083
• Other study ID #: Zhou peijie-2024ky-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: January 2024
• Source: Anhui Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Squamous Cell Carcinoma
• Immunotherapy
• Radiotherapy
• Uterine Cervical Neoplasms

Intervention

Radiation:
• PLDR+Cardunizumab
Application of PLDR external irradiation combined with Cardunizumab in recurrent cervical cancer

Locations

Country	Name	City	State
China	The First Affiliated Hospital of University of Science and Technology of China	Hefei	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	6 month post PLDR external irradiation
Secondary	Toxic side effects		6 month post PLDR external irradiation