PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

NCT04815408 | Unknown Phase 2

• 1 other identifier: Z2HOC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

  12 months

Secondary Outcomes (5)

• R0 rate

  after interval debulking surgery for one week

• CRR

  3 months

• PRR

  3 months

• OS

  5 years

• AEs

  3 months

Study Arms (2)

NIC

EXPERIMENTAL

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)

Drug: BGB-A317; Drug: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

NC

ACTIVE COMPARATOR

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)

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

Interventions

BGB-A317 DRUG

PD-1 antibody，Tislelizumab (BGB-A317)

NIC

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

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

NC; NIC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of ovary, fallopian tube, primary peritoneum (Non-mucinous adenocarcinoma)
• Clinical stage IIIC/IV, and IIIC with Suidan CT ≥3 or Fagotti ≥8
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 2
• Not received any immunotherapy before
• Willing to participate in this study, and sign the informed consent.

You may not qualify if:

• With other uncontrolled malignant tumors.
• 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.
• 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.
• A history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases (including pulmonary fibrosis, acute lung disease, etc.).
• 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).
• Known human immunodeficiency virus (HIV) infection (known to be HIV positive).
• 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).
• With uncontrolled cardiac clinical symptoms or diseases.
• Allergic to any drug in this program.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39909529 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

tislelizumab; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jianwei Zhou, MD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Zhigang Zhang, MD

CONTACT

+86057189713631; zzg2011@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2025
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

CN (1)