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AK104 Combined With I-125 Brachytherapy for Recurrent or Metastatic Cervical Cancer

NCT06062589 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2023-10-02

No results posted yet for this study

Summary

The goal of this study is to determine efficacy and safety of AK104 combined with I-125 brachytherapy for recurrent or metastatic cervical cancer.

This is an open-label, single-center, observational study of AK104 with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer. 18 eligible patients will receive Iodine-125 brachytherapy (single implantation, half-life of 60 days, 99% of total dose given after 90 days), followed by AK104 treatment (6mg/kg Q2W) starting within 1 week of particle implantation, for a total of 6 cycles or until disease progression, intolerable toxicity, investigator decision, withdrawal of informed consent, death, or other reasons as specified in the protocol.

Conditions

Interventions

RADIATION

Iodine-125 particle brachytherapy

All enrolled patients' relapsed or metastatic lesions underwent image-guided radiation I-125 particle implantation brachytherapy (single implantation, half-life of 60 days, 99% of total dose given after 90 days). The prescribed dose is above 130Gy. Technical process: positioning and preoperative planning design; Template reset and particle implantation under the guidance of image system; Rapid and real-time intraoperative optimization; Postoperative dose validation.

DRUG

AK104

AK104 treatment (6mg/kg Q2W) starting within 1 week of particle implantation, for a total of 6 cycles or until disease progression, intolerable toxicity, investigator decision, withdrawal of informed consent, death, or other reasons as specified in the protocol.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2025-01-11
Completion
2027-10-11

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Entities

Diseases

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 NCT06062589 on ClinicalTrials.gov