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)

Sponsors

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Source Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Overall Status Recruiting
Start Date 2021-04-01
Completion Date 2025-04-01
Primary Completion Date 2023-04-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Progression-free survival(PFS) 12 months
Secondary Outcome
Measure Time Frame
R0 rate after interval debulking surgery for one week
CRR 3 months
PRR 3 months
OS 5 years
AEs 3 months
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: BGB-A317

Description: PD-1 antibody,Tislelizumab (BGB-A317)

Arm Group Label: NIC

Intervention Type: Drug

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

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

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.

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jianwei Zhou, MD Study Chair Second Affiliated Hospital of Zhejiang University School of Medicine
Overall Contact

Last Name: Zhigang Zhang, MD

Phone: +86057189713631

Email: [email protected]

Location
Facility: Status: Contact: Second Affiliated Hospital of Zhejiang University School of Medicine Zhigang Zhang, MD +86057189713631 [email protected]
Location Countries

China

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: NIC

Type: Experimental

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)

Label: NC

Type: Active Comparator

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)

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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