Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06413992
PHASE2

Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This study is an open-label Phase II randomized controlled trial designed to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer. The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance.

Official title: Efficacy and Safety of Camrelizumab Plus Albumin-bound Paclitaxel/Carboplatin Followed by Camrelizumab With or Without Fluzoparib Maintenance Therapy for TP-53 Mutated Recurrent or Metastatic Endometrial Cancer: A Phase II Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2024-05-10

Completion Date

2027-06-01

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

DRUG

Fluzoparib

During the maintenance phase of treatment. Oral administration of Fluzoparib capsules at a dose of 150mg(N=78 participants), once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.

DRUG

Camrelizumab

During the maintenance phase of treatment. Camrelizumab, 200 mg administered intravenously every 3 weeks until disease progression, intolerable toxicity, death, or up to 2 years.

DRUG

paclitaxel (albumin bound)

Paclitaxel (albumin-bound) for injection, 260 mg/m\^2 administered intravenously in 3-week cycles for 6 cycles.

DRUG

Carboplatin injection

AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator

DRUG

Carboplatin

AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator

RADIATION

External irradiation

Non-essential, decision to combine is made by the principal investigator based on the patient's condition.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China