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Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma

NCT06805864 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-02-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if pembrolizumab works for cervical adenocarcinoma treat with concurrent chemo-carbon-ion radiaotherapy (CIRT).

The main questions it aims to answer are:

• Does concurrent chemo-CIRT with pembrolizumab improves 2-year progression-free survival (PFS), compared with concurrent chemoradiotherapy with conventional X-rays?

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma

Interventions

DRUG

Pembrolizumab (KEYTRUDA®)

Pembrolizumab is administered at 200 mg every 3 weeks for the first 2 cycles during Chemo-CIRT, after completion of radiotherapy, the dose is increased to 400 mg and given every 6 weeks for a total of 17 cycles over 2 years.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805864 on ClinicalTrials.gov