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

NCT06600841 | Not Yet Recruiting Phase 2

• 1 other identifier: SY-OC
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platinum-resistant Ovarian Cancer (PROC); Immunotherapy

Keywords

Platinum-resistant Ovarian Cancer (PROC); adebrelimab; Fuzuloparib

Outcome Measures

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.

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

Secondary Outcomes (4)

• Progression-free survival (PFS)

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

• Disease Control Rate(DCR)

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

• Overall survival (OS)

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

• Adverse events (AEs)

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

Other Outcomes (2)

• Detection of PD-L1 expression level

  36 months

• Detection of HRD status

  36 months

Study Arms (1)

Immunotherapy group

EXPERIMENTAL

Drug: Adebrelimab, Non-platinum chemotherapy（Doxorubicin liposome/Paclitaxel-albumin/ or Gemcitabine）, fluzoparib Intervention：Adebrelimab plus Non-platinum chemotherapy（Doxorubicin liposome/Paclitaxel-albumin/ or Gemcitabine） induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib.

Drug: Immunotherapy（Adebrelimab）

Interventions

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 group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ECOG PS 0-1;
• Major organ functions are normal and meet the following criteria:(1) Blood routine inspection standards must meet: (no blood transfusion within 14 days)a.HB≥100g/L, b. WBC≥3×10\^9/L c. ANC≥1.5×10\^9/L, d.PLT≥100×10\^9/L; (2) Biochemical examination must meet the following standards: a. BIL ≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.5×ULN, ALT and AST≤5×ULN in patients with liver metastases; c. Serum Cr≤1.5×ULN
• Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international normalized ratio (INR) ≤ 1.5 times ULN, unless the patient is receiving anticoagulation, as long as PT or APTT is within the expected range of anticoagulant use;
• No severe heart, lung, liver or kidney disorders;
• Women of childbearing age must have a pregnancy test (serum) within seven days before enrollment, have a negative result, and be willing to use appropriate methods of contraception during the trial period and eight weeks after the last administration of the test drug;
• Estimated survival≥ 12 weeks;
• Sign a written informed consent form and be able to comply with the visitation and related procedures set out in the program.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Fujian Provincial Hospital: collaborator

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Central Study Contacts

YANG Sun, PHD

CONTACT

15959028989; sunyang@fjzlhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)