Status:
RECRUITING
AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
Lead Sponsor:
Hunan Cancer Hospital
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile. AK104 is a bis...
Eligibility Criteria
Inclusion
- Key
- \- 1. Woman ≥ 18 and ≤ 75 years old on day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended.
- 4\. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 5. Have adequate organ function.
- Key
Exclusion
- 1\. Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary.
- 2\. Patients with other active malignancies within 5 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- 5\. Presence of other uncontrolled serious medical conditions.
Key Trial Info
Start Date :
November 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05430906
Start Date
November 25 2022
End Date
January 1 2026
Last Update
April 25 2023
Active Locations (1)
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1
Hunan Cancer hospital
Changsha, Hunan, China, 410000