Advanced Ovarian CancerPhase 3NCT06542549
Efficacy and Safety of AK104 Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer
A Phase 3 study testing AK104 in people with Advanced Ovarian Cancer and AK104(PD-1/CTLA-4 Bispecial Antibody), run by Anhui Provincial Hospital at 1 site in China.
Trial summary
This is a randomized, controlled, multicenter clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Ovarian Cancer, AK104(PD-1/CTLA-4 Bispecial Antibody), Chemotherapy
- What is being tested?
- AK104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 31 Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Agree to sign the informed consent form.
- 18 years ≤ age <75 years, female.
- Patients with histopathologically confirmed epithelial ovarian cancer (high-grade serous adenocarcinoma, endometrioid adenocarcinoma of the ovary, clear cell carcinoma), peritoneal cancer, fallopian tube cancer, carcinosarcoma, malignant Brenner tumor, mesonephric carcinoma, undifferentiated/dedifferentiated carcinoma, mixed carcinoma and hypercalcemic small cell carcinoma, FIGO 2018 stage III-IV.
- Evidence of compliance with neoadjuvant chemotherapy for ovarian cancer: (a) Preoperative evaluation by gynecologic oncologists (multidisciplinary if necessary) indicates that R0 resection is less likely to be achieved after primary tumor reduction; (b) Patients whose physical state cannot tolerate PDS and are not suitable for immediate surgery (such as perioperative high risk, old age, medical complications, etc.); (c) Without any systematic anti-tumor therapy for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy); Note: Histopathology is obtained by puncture biopsy, laparoscopic exploration, etc. Lymph node resection or biopsy for clinical staging purposes is permitted.
- Those with at least one measurable lesion (RECIST version 1.1).
- ECOG Physical status score 0-2.
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- Estimated survival time > 12 weeks.
- Good organ function.
- Participants of reproductive age must agree to use effective contraception during the trial; Serum or urine pregnancy tests for women of childbearing age must be negative.
- Non-lactating patients.
Who cannot join
- Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (such as germ cell tumor) of non-epithelial origin; Ovarian tumors with low malignant potential (e.g., borderline tumors).
- Patients with other malignant tumors in the past (within 5 years) or at the same time, with the exception of cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer with no recurrence >3 years after radical surgery.
- Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBV surface antigen [HBsAg] positive) with HBV DNA > 1000 IU/mL, and subjects with active viral hepatitis C. Note: Inactive or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU/mL were admitted. Subjects with cured viral hepatitis C, HCVAb positive and HCV RNA negative were admitted.
- A history of testing positive for known human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Have an active or possibly recurring autoimmune disease; The following are excluded: vitiligo, alopecia, psoriasis or eczema that do not require systematic treatment; Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormone replacement therapy; Only a steady dose of insulin replacement is required for type 1 diabetes.
- A history of severe allergic reactions to any monoclonal antibody and/or investigational drug ingredient.
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- Subjects with known active TB and suspected active TB should undergo clinical examination to rule out known active syphilis infection.
- There is a history or current presence of noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy.
- Severe infections occurring within 4 weeks prior to first dosing, including but not limited to active infections with comorbidification requiring hospitalization, sepsis, or severe pneumonia that received systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).
- Serious medical conditions or concomitant non-oncological conditions, such as neurological disorders, psychosis, infectious diseases, or laboratory abnormalities, may increase the risk of participating in the study or taking the investigational drug, which the investigator believes would make the patient unfit for entry into the study.
- Patients with clinically significant cardiovascular disease.
- Patients who were judged by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hanjie Xu contact
China1 site, 1 recruiting
- Recruiting
Anhui Provicial Hospital
Hefei, Anhui, 230001
Hanjie Xu, +8613965141720
About this study
Official title: Efficacy and Safety of AK104 (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study
This is a randomized, controlled, multicenter clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.
Read the detailed description
Subjects in the experimental group received AK104 combined chemotherapy for 3-4 cycles (determined by the investigator) before surgery, and subjects in the control group received chemotherapy for 3-4 cycles (determined by the investigator) before surgery. Treatment until unless intolerable toxicity occurs, informed consent is withdrawn, or other criteria for discontinuation are met.
The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment.
- Conditions
- Advanced Ovarian Cancer, AK104(PD-1/CTLA-4 Bispecial Antibody), Chemotherapy, Efficacy, Safety
- Being tested
- AK104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment.
| Study group | Role | What they receive |
|---|---|---|
| AK104 combined with chemotherapy | Experimental | 10mg/kg, administered every three weeks. The drug was administered by intravenous infusion for 60 minutes (±10 minutes). For subjects who cannot tolerate a 60-minute infusion, the infusion time can be extended up to 120 minutes. Dose adjustment is not allowed during treatment; Delayed dosing is allowed. Receives: Drug: AK104 |
| chemotherapy only | No intervention | Conventional chemotherapy regimen can be selected: ① Paclitaxel: 175mg/㎡, intravenous infusion d1+ carboplatin AUC5, intravenous infusion d1, Q3W; ② Paclitaxel (albumin-bound type) 260mg/m2 d1+ carboplatin AUC 5, d1, Q3W; (Limited to patients who are allergic to solvent-based paclitaxel solute (polyoxyethylene castor oil) or to paclitaxel/docetaxel, paclitaxel (albumin-bound type) can be substituted in the combination regimen), ③ paclitaxel (albumin-bound type) 260mg/m2 d1+ cisplatin: 75mg/m2 d1, Q3W. (Limited to patients who are allergic to solvent-based paclitaxel solutes (polyoxyethylene castor oil) or to paclitaxel/docetaxel, paclitaxel (albumin-bound) can be substituted in the combination regimen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 rate
Rate of complete tumor resection (R0): complete resection of the visible lesion.
Measured: Up to 6 months
Secondary outcomes (5)
ORR
Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
Measured: 1 year
DCR
Disease control rate (DCR) refers to the percentage of cases with remission and disease stability after treatment in the total number of evaluable cases.
Measured: 1 year
pCR
Pathological complete response is the breast primary focus and axillary lymph node surgery specimen pathological examination without invasive tumor cell residual.
Measured: 1 year
PFS
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Measured: 1 year
AE
adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start11 Mar 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in the experimental group received AK104 combined chemotherapy for 3-4 cycles (determined by the investigator) before surgery, and subjects in the control group received chemotherapy for 3-4 cycles (determined by the investigator) before surgery.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542549
- Sponsor's protocol ID
- ZhouYing-Remat
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AK104 (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT06542549
- Acronym / sponsor ID
- ZhouYing-Remat
- Conditions
- Advanced Ovarian Cancer, AK104(PD-1/CTLA-4 Bispecial Antibody), Chemotherapy, Efficacy, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 7 Aug 2024 (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.
This is a randomized, controlled, multicenter clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.
Detailed description
Subjects in the experimental group received AK104 combined chemotherapy for 3-4 cycles (determined by the investigator) before surgery, and subjects in the control group received chemotherapy for 3-4 cycles (determined by the investigator) before surgery. Treatment until unless intolerable toxicity occurs, informed consent is withdrawn, or other criteria for discontinuation are met.
The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects in the experimental group received AK104 combined chemotherapy for 3-4 cycles (determined by the investigator) before surgery, and subjects in the control group received chemotherapy for 3-4 cycles (determined by the investigator) before surgery.
| Arm | Type | Receives |
|---|---|---|
| AK104 combined with chemotherapy | Experimental | Drug: AK10410mg/kg, administered every three weeks. The drug was administered by intravenous infusion for 60 minutes (±10 minutes). For subjects who cannot tolerate a 60-minute infusion, the infusion time can be extended up to 120 minutes. Dose adjustment is not allowed during treatment; Delayed dosing is allowed. |
| chemotherapy only | No intervention | –Conventional chemotherapy regimen can be selected: ① Paclitaxel: 175mg/㎡, intravenous infusion d1+ carboplatin AUC5, intravenous infusion d1, Q3W; ② Paclitaxel (albumin-bound type) 260mg/m2 d1+ carboplatin AUC 5, d1, Q3W; (Limited to patients who are allergic to solvent-based paclitaxel solute (polyoxyethylene castor oil) or to paclitaxel/docetaxel, paclitaxel (albumin-bound type) can be substituted in the combination regimen), ③ paclitaxel (albumin-bound type) 260mg/m2 d1+ cisplatin: 75mg/m2 d1, Q3W. (Limited to patients who are allergic to solvent-based paclitaxel solutes (polyoxyethylene castor oil) or to paclitaxel/docetaxel, paclitaxel (albumin-bound) can be substituted in the combination regimen) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Agree to sign the informed consent form.
- 18 years ≤ age <75 years, female.
- Patients with histopathologically confirmed epithelial ovarian cancer (high-grade serous adenocarcinoma, endometrioid adenocarcinoma of the ovary, clear cell carcinoma), peritoneal cancer, fallopian tube cancer, carcinosarcoma, malignant Brenner tumor, mesonephric carcinoma, undifferentiated/dedifferentiated carcinoma, mixed carcinoma and hypercalcemic small cell carcinoma, FIGO 2018 stage III-IV.
- Evidence of compliance with neoadjuvant chemotherapy for ovarian cancer: (a) Preoperative evaluation by gynecologic oncologists (multidisciplinary if necessary) indicates that R0 resection is less likely to be achieved after primary tumor reduction; (b) Patients whose physical state cannot tolerate PDS and are not suitable for immediate surgery (such as perioperative high risk, old age, medical complications, etc.); (c) Without any systematic anti-tumor therapy for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy); Note: Histopathology is obtained by puncture biopsy, laparoscopic exploration, etc. Lymph node resection or biopsy for clinical staging purposes is permitted.
- Those with at least one measurable lesion (RECIST version 1.1).
Key exclusion criteria (12 listed)
- Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (such as germ cell tumor) of non-epithelial origin; Ovarian tumors with low malignant potential (e.g., borderline tumors).
- Patients with other malignant tumors in the past (within 5 years) or at the same time, with the exception of cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer with no recurrence >3 years after radical surgery.
- Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBV surface antigen [HBsAg] positive) with HBV DNA > 1000 IU/mL, and subjects with active viral hepatitis C. Note: Inactive or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU/mL were admitted. Subjects with cured viral hepatitis C, HCVAb positive and HCV RNA negative were admitted.
- A history of testing positive for known human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Have an active or possibly recurring autoimmune disease; The following are excluded: vitiligo, alopecia, psoriasis or eczema that do not require systematic treatment; Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormone replacement therapy; Only a steady dose of insulin replacement is required for type 1 diabetes.
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 |
|---|---|---|
| AK104The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment. | Drug | AK104 combined with chemotherapy |
Primary outcome
R0 rate
Time frame: Up to 6 months
Rate of complete tumor resection (R0): complete resection of the visible lesion.
5 secondary outcomes
ORR
Time frame: 1 year
DCR
Time frame: 1 year
pCR
Time frame: 1 year
PFS
Time frame: 1 year
AE
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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.
Hanjie Xu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK104 in people with Advanced Ovarian Cancer and AK104(PD-1/CTLA-4 Bispecial Antibody), run by Anhui Provincial 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 10 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou (0551-62283954, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 rate (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.