Image

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

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

Recruiting
20-70 years
Female
Phase 1/2

Powered by AI

Overview

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

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.

Study details
    Cervical Squamous Cell Carcinoma
    Radiotherapy
    Immunotherapy

NCT06232083

Anhui Provincial Hospital

16 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.