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PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

A Phase II Study of PD-1 Antibody Plus Neoadjuvant Chemotherapy for Advanced-stage Ovarian Cancer (Z2HOC-01)

NCT04815408•Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

April 1, 2021

Primary Completion Date

April 1, 2023

Completion Date

April 1, 2025

Last Updated

March 25, 2021

Enrollment

ESTIMATED participants

Conditions

Ovarian CancerNeoadjuvant ChemotherapyAnti-PD-1Neoadjuvant Immunotherapy

Interventions

BGB-A317

DRUG

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

DRUG

Contacts

Zhigang Zhang, MD

CONTACT

+86057189713631 zzg2011@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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