- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815408
PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer
March 23, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
A Phase II Study of PD-1 Antibody Plus Neoadjuvant Chemotherapy for Advanced-stage Ovarian Cancer (Z2HOC-01)
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhigang Zhang, MD
- Phone Number: +86057189713631
- Email: zzg2011@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Recruiting
- Second Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Zhigang Zhang, MD
- Phone Number: +86057189713631
- Email: zzg2011@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NIC
|
PD-1 antibody,Tislelizumab (BGB-A317)
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
|
Active Comparator: NC
|
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival(PFS)
Time Frame: 12 months
|
12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 rate
Time Frame: after interval debulking surgery for one week
|
R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)
|
after interval debulking surgery for one week
|
CRR
Time Frame: 3 months
|
CRR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response.
The CRR will be assessed by a blind independent central reviewer per RECIST 1.1
|
3 months
|
PRR
Time Frame: 3 months
|
At interval cytoreduction pathologic complete remission rate will be measured using RECIST and immune-related response criteria.
|
3 months
|
OS
Time Frame: 5 years
|
OS is defined as the time from the date of randomization until death.
|
5 years
|
AEs
Time Frame: 3 months
|
Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jianwei Zhou, MD, Second Affiliated Hospital of Zhejiang University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2021
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2025
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2021
Last Update Submitted That Met QC Criteria
March 23, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- Z2HOC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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