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Adebrelimab Combined with Non-platinum Chemotherapy and Fuzuloparib in Recurrent Platinum-resistant Ovarian Cancer

ConditionsPlatinum-resistant Ovarian Cancer (PROC)Immunotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFujian Cancer Hospital

About this trial

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus Non-platinum chemotherapy and Fuzuloparib (PARP inhibitor) induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib in platinum-resistant relapsed/metastatic ovarian cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70; Female;

Pathologically (including histologically) confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (hereinafter referred to as ovarian cancer), recurrence within less than six months after the last treatment with platinum-containing chemotherapy;

Patients have at least one target lesion with measurable dimensions according to RECIST1.1 criteria;

HRR gene mutation confirmed by testing tissue or blood samples;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Immunotherapy（Adebrelimab）

    Drug

    Adebrelimab plus non-platinum chemotherapy（Liposomal doxorubicin/Gemcitabine/ or nab-paclitaxel）and fluzoparib induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib.

  • immunotherapy（Adebrelimab）

    Drug

    anti-PD-L1

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Immunotherapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate(ORR)

Objective Response Rate(ORR) was defined as the percentage of participants with the best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, defined as the best response recorded from the start of the study treatment until disease progression/recurrence or death. Participants needed two consecutive assessments of PR or CR to be responders. Only participants with measurable disease at baseline were included in the analysis of BOR, and those who did not have any evaluable post-baseline assessments were classified as not evaluable.

Time frame
From the enrollment to the final documentation of response of the last subject (assessed up to 36 months)

Secondary outcomes

1

Progression-free survival (PFS)

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

Time frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
2

Disease Control Rate(DCR)

DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

Time frame
From the enrollment to death, lost to follow-up, withdrawal, or study end, whichever occurred first, assessed up to 36 months
3

Overall survival (OS)

defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization. The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

Time frame
From the enrollment to the death of last subject or the end of the clinical trial (assessed up to 36 months)
4

Adverse events (AEs)

The incidence and severity of AEs, abnormalities in physical exams, vital sign assessments, clinical laboratory assessments

Time frame
from the initiation of the first dose to 28 days after the last dose，assessed up to 36 months

Other outcomes

1

Detection of PD-L1 expression level

Exploration outcome . Detection of PD-L1 expression level in tumor tissue by Immunohistochemistry

Time frame
36 months
2

Detection of HRD status

Exploration outcome . Detection of HRD status in tumor tissue or peripheral blood by next-generation sequencing （NGS）.

Time frame
36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Fujian Provincial Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: