Clinical trial NCT04815408: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer
Neoadjuvant Chemotherapy
Anti-PD-1
Neoadjuvant Immunotherapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 12 months
Secondary outcomes:
measure: R0 rate
timeFrame: after interval debulking surgery for one week
measure: CRR
timeFrame: 3 months
measure: PRR
timeFrame: 3 months
measure: OS
timeFrame: 5 years
measure: AEs
timeFrame: 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Jianwei Zhou, MD
role: STUDY_CHAIR
References: