Ovarian CancerPhase 2NCT05430906
AK104 Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer
A Phase 2 study testing AK104 - Chemotherapy in people with Ovarian Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial 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 bispecific antibody targeting PD-1 and CTLA-4. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- AK104 - Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2022to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan, 410000
Jie Tang
About this study
Official title: Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
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 bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- AK104 - Chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104 - ChemotherapyDrug
AK104 10mg/kg then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)] of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| AK104+chemotherapy | Experimental | Participants received 3-4 neo-adjuvant cycles of AK104 10mg/kg Q3W then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)] Q3W; followed by surgery Receives: Drug: AK104 - Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete(R0) resection rate
The margin of the resected specimen showed no tumour involvement
Measured: Average 4 months after the start of drugs
Secondary outcomes (6)
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Measured: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.
Measured: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Pathological Complete Response (pCR) Rate
The pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: One week after the surgery
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of drugs until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: From the date of the start of drugs to date event, assessed up to 1 years
Number of participants with adverse events (AEs)
Measured: From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment
Number of participants with surgical complications
Measured: Intraoperatively, within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start25 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Tang, Study chair, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430906
- Sponsor's protocol ID
- AK104-IIT-003
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang C, Dai M, Yang J, Tian W, Huang S, Bi F, Zheng K, Tang J. Patient with HR-proficient advanced ovarian cancer achieved a complete response with Cadonilimab combined chemotherapy (PD-1/CTLA-4 bispecific): a case report and literature review. Gynecol Oncol Rep. 2025 Jun 15;60:101785. doi: 10.1016/j.gore.2025.101785. eCollection 2025 Aug.
PubMed 40600147
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05430906
- Acronym / sponsor ID
- AK104-IIT-003
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104+chemotherapy | Experimental | Drug: AK104 - ChemotherapyParticipants received 3-4 neo-adjuvant cycles of AK104 10mg/kg Q3W then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)] Q3W; followed by surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104 - ChemotherapyAK104 10mg/kg then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)] of each 21-day cycle | Drug | AK104+chemotherapy |
Primary outcome
Complete(R0) resection rate
Time frame: Average 4 months after the start of drugs
The margin of the resected specimen showed no tumour involvement
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Disease control rate (DCR)
Time frame: At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days)
Pathological Complete Response (pCR) Rate
Time frame: One week after the surgery
Progression-free survival (PFS)
Time frame: From the date of the start of drugs to date event, assessed up to 1 years
Number of participants with adverse events (AEs)
Time frame: From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment
Number of participants with surgical complications
Time frame: Intraoperatively, within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 40600147Zhang C, Dai M, Yang J, Tian W, Huang S, Bi F, Zheng K, Tang J. Patient with HR-proficient advanced ovarian cancer achieved a complete response with Cadonilimab combined chemotherapy (PD-1/CTLA-4 bispecific): a case report and literature review. Gynecol Oncol Rep. 2025 Jun 15;60:101785. doi: 10.1016/j.gore.2025.101785. eCollection 2025 Aug.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Tang study chair
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104 - Chemotherapy in people with Ovarian Cancer, run by Hunan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Tang (+8615274836636, tangjie@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete(R0) resection rate (time frame: Average 4 months after the start of drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05430906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.