search
Back to results

PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

Primary Purpose

Ovarian Cancer, Neoadjuvant Chemotherapy, Anti-PD-1

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BGB-A317
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIC

NC

Arm Description

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

Neoadjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing) Interval debulking surgery and HIPEC Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

R0 rate
R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)
CRR
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
PRR
At interval cytoreduction pathologic complete remission rate will be measured using RECIST and immune-related response criteria.
OS
OS is defined as the time from the date of randomization until death.
AEs
Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy

Full Information

First Posted
March 23, 2021
Last Updated
March 23, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT04815408
Brief Title
PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer
Official Title
A Phase II Study of PD-1 Antibody Plus Neoadjuvant Chemotherapy for Advanced-stage Ovarian Cancer (Z2HOC-01)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Neoadjuvant Chemotherapy, Anti-PD-1, Neoadjuvant Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIC
Arm Type
Experimental
Arm Description
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) Interval debulking surgery and HIPEC Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)
Arm Title
NC
Arm Type
Active Comparator
Arm Description
Neoadjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing) Interval debulking surgery and HIPEC Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)
Intervention Type
Drug
Intervention Name(s)
BGB-A317
Intervention Description
PD-1 antibody,Tislelizumab (BGB-A317)
Intervention Type
Drug
Intervention Name(s)
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
Intervention Description
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
Primary Outcome Measure Information:
Title
Progression-free survival(PFS)
Description
12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
R0 rate
Description
R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)
Time Frame
after interval debulking surgery for one week
Title
CRR
Description
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
Time Frame
3 months
Title
PRR
Description
At interval cytoreduction pathologic complete remission rate will be measured using RECIST and immune-related response criteria.
Time Frame
3 months
Title
OS
Description
OS is defined as the time from the date of randomization until death.
Time Frame
5 years
Title
AEs
Description
Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhigang Zhang, MD
Phone
+86057189713631
Email
zzg2011@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwei Zhou, MD
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Zhang, MD
Phone
+86057189713631
Email
zzg2011@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

We'll reach out to this number within 24 hrs