PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04815408
• Other study ID #: Z2HOC-01
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhigang Zhang, MD
• Phone: +86057189713631
• Email: zzg2011[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-PD-1
• Carcinoma, Ovarian Epithelial
• Neoadjuvant Chemotherapy
• Neoadjuvant Immunotherapy
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• BGB-A317
PD-1 antibody,Tislelizumab (BGB-A317)
• albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival(PFS)	12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.	12 months
Secondary	R0 rate	R0 rate of IDS(interval debulking surgery) after neoadjuvant chemotherapy(after the completion of 3rd cycle)	after interval debulking surgery for one week
Secondary	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	3 months
Secondary	PRR	At interval cytoreduction pathologic complete remission rate will be measured using RECIST and immune-related response criteria.	3 months
Secondary	OS	OS is defined as the time from the date of randomization until death.	5 years
Secondary	AEs	Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 in neoadjuvant chemotherapy	3 months