PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

NCT ID: NCT04815408

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-04-01

Brief Summary

The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.

Conditions

Ovarian Cancer; Neoadjuvant Chemotherapy; Anti-PD-1; Neoadjuvant Immunotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NIC

1. Neoadjuvant treatment BGB-A317 200mg q3 weeks (total 3 dosing) Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)

2. Interval debulking surgery and HIPEC

3. Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)

Group Type: EXPERIMENTAL

BGB-A317

Intervention Type: DRUG

PD-1 antibody，Tislelizumab (BGB-A317)

albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

Intervention Type: DRUG

albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

NC

1. Neoadjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)

2. Interval debulking surgery and HIPEC

3. Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)

Group Type: ACTIVE_COMPARATOR

albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

Intervention Type: DRUG

albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

Interventions

BGB-A317

PD-1 antibody，Tislelizumab (BGB-A317)

Intervention Type: DRUG

albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of ovary, fallopian tube, primary peritoneum (Non-mucinous adenocarcinoma)

2. Clinical stage IIIC/IV, and IIIC with Suidan CT ≥3 or Fagotti ≥8

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 2

4. Not received any immunotherapy before

5. Willing to participate in this study, and sign the informed consent.

Exclusion Criteria

1. With other uncontrolled malignant tumors.

2. Any disease requiring systemic treatment with a corticosteroid (prednisone or equivalent daily dose of > 10mg) or other immunosuppressive agents during the 14 days prior to randomization.The use of topical substitute steroids (daily dose ≤10mg of prednisone or its equivalent) and prescription corticosteroids for short-term (≤7 days) prophylactic use or for the treatment of non-autoimmune conditions is permitted.Has any active autoimmune disease or a history of autoimmunity.

3. A history of active autoimmune disease or autoimmune disease that may recur.Enrolment was allowed for well-controlled type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, well-controlled celiac disease, skin conditions (such as vitiligo, psoriasis, or alopecia) that did not require systemic treatment, or conditions that were not expected to recede without an external cause.

4. A history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases (including pulmonary fibrosis, acute lung disease, etc.).

5. Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen [HBsAg] test result and HBV-DNA test value higher than the upper limit of normal value in the laboratory of the research center) or hepatitis C (defined as positive hepatitis C virus surface antibody [HCSAB] test result and positive HCV-RNA test result).

6. Known human immunodeficiency virus (HIV) infection (known to be HIV positive).

7. Have received live vaccine within 30 days before the first administration.This includes but is not limited to the following: mumps, rubella, measles, varicella/herpes zoster (varicella), yellow fever, rabies, BCG and typhoid vaccines (inactivated virus vaccines are allowed).

8. With uncontrolled cardiac clinical symptoms or diseases.

9. Allergic to any drug in this program.

10. At the discretion of the Investigator, the subject has a history or current evidence of any disease, treatment or laboratory anomaly that may confuse the results, interfere with the participants' participation throughout the study, or is not in the best interest of the participants to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianwei Zhou, MD

Role: STUDY_CHAIR

Second Affiliated Hospital of Zhejiang University School of Medicine

Locations

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhigang Zhang, MD

Role: CONTACT

zzg2011@zju.edu.cn

+86057189713631

Facility Contacts

Zhigang Zhang, MD

Role: primary

zzg2011@zju.edu.cn

+86057189713631

References

Zhu Y, Fei J, Zhu X, Zhang J, Zhou J, Zhang Z. Efficacy and safety of NeoAdjuvant chemotherapy with or without tIslelizumab followed by debulking surgery for oVarian cancEr (NAIVE study) in China: study protocol of an open-label, phase II, randomised controlled trial. BMJ Open. 2025 Feb 5;15(2):e092545. doi: 10.1136/bmjopen-2024-092545.

Reference Type: DERIVED

PMID: 39909529 (View on PubMed)

Other Identifiers

Z2HOC-01

Identifier Type: -

Identifier Source: org_study_id