Ovarian CancerPhase 3NCT07779538
Clinical Trials Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer
A Phase 3 study testing trastuzumab and bevacizumab in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 3 sites in China.
Trial summary
This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- trastuzumab and bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 3 sitesChina
- Study dates
- 20 Oct 2026to 30 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily join this trial and sign an informed consent form.
- Newly diagnosed stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by histological or cytological pathology.
- Prior to first-line platinum-based doublet chemotherapy combined with bevacizumab.
- No disease progression as assessed by the investigator after completion of first-line platinum-based therapy and before randomization.
- Participants' homologous recombination deficiency test results must meet the criteria.
- Participants have not received any anti-tumor therapy from the last dose of first-line platinum-based therapy until randomization.
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- Able to provide sufficient fresh or archived tumor tissue specimens for testing at the sponsor-designated central laboratory.
- ECOG PS score: 0-1.
- Expected survival ≥ 12 weeks.
- Laboratory tests within 7 days prior to randomization confirm that important organ function meets the requirements.
- Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to randomization and must not be breastfeeding; female participants of childbearing potential must agree to adhere to contraception from the date of signing the informed consent form until 7 months after the last dose.
Who cannot join
- Participants with untreated or active central nervous system (CNS) metastases; a history of meningeal metastases or current meningeal metastases.
- Participants with clinically symptomatic, poorly controlled, or moderate to severe pleural effusion, pericardial effusion, or ascites.
- Participants with a history of or concurrent other malignancies, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥5 years prior to randomization with evidence of no recurrence or metastasis.
- Participants with a history of interstitial pneumonia/interstitial lung disease requiring steroid treatment, non-infectious pneumonia (such as radiation pneumonitis), current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonia, or other active pneumonia; or those with severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or other lung damage within 6 months prior to randomization.
- 6. Individuals with active pulmonary tuberculosis; those who have received adequate and regular treatment and have stopped anti-tuberculosis treatment for ≥3 months prior to randomization are eligible for enrollment.
- 7. Individuals with poorly controlled or severe cardiovascular disease. 8. Individuals who have experienced arterial/venous thrombotic events within 6 months prior to randomization.
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- 9. Individuals who have experienced NCI-CTCAE v6.0 grade ≥2 bleeding events within 1 month prior to randomization.
- 10. Individuals with known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendency.
- 11. Individuals who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess in the near future.
- 12. Individuals with gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 3 months prior to randomization; individuals who have previously undergone intestinal stent implantation and whose intestinal stent has not been removed by the screening period.
- 13. Participants who have experienced severe infection within 1 month prior to randomization.
- 14. Participants who have tested positive for human immunodeficiency virus (HIV); participants with known active hepatitis.
- 15. Participants who have undergone major surgery within 4 weeks prior to randomization or whose surgical side effects have not recovered or stabilized prior to randomization. 16. Patients who may receive other systemic anti-tumor therapies during treatment or are scheduled for further debulking surgery.
- 17. Patients whose toxicity from previous anti-tumor therapy has not recovered to grade ≤1 according to the NCI-CTCAE v6.0 classification.
- 18. Patients with known hypersensitivity to any component of the SHR-A1811 product or other monoclonal antibody drugs.
- 19. Patients who, in the investigator's judgment, have other factors that may affect the trial results or force the trial to be terminated midway, such as alcoholism, drug abuse, substance abuse, criminal detention, etc., as well as other serious illnesses (including mental illness) requiring concomitant treatment, serious abnormal laboratory test results, or any other circumstances that may increase the risk of participation in the trial, interfere with the trial results, or make them unsuitable for participation in the trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100020
Lingying Wu, 010-67781331, wulingying@csco.org.cn
- Recruiting
Yunnan Cancer Hospital
Yunnan, Kunming, 650118
Hongying Yang, 0871-68189037, yanghy913@126.com
- Recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou
Tao Zhu, 0571-88122222, zhutao@zjcc.org.cn
About this study
Official title: A Randomized, Open-label, Multicenter Phase Ib/III Clinical Trial Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer
This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.
- Conditions
- Ovarian Cancer
- Being tested
- trastuzumab, bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabDrug
trastuzumab
bevacizumabDrug
bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: trastuzumab; Drug: bevacizumab |
| Treatment group B | Other | Not described Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT)
Measured: up to 21 days
Progression Free Survival (PFS)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Secondary outcomes (11)
AEs+SAEs
Measured: from the first drug administration to within 40 days for the last treatment dose
Ctrough
Measured: from the first drug administration to within 40 days for the last treatment dose
ADA
Measured: from the first drug administration to within 40 days for the last treatment dose
Overall survival (OS)
Measured: Approximately 3 years after last subject enrolled
Second progression-free survival (PFS2)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Objective Response Rate (ORR)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Disease Control Rate (DCR)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Duration of Response (DoR)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to disease progression (TTP)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Cancer antigen-125 response rate (CA-125 RR)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to the start of subsequent treatment (TFST)
Measured: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Oct 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779538
- Sponsor's protocol ID
- SHR-A1811-321
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase Ib/III Clinical Trial Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07779538
- Acronym / sponsor ID
- SHR-A1811-321
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 21 Aug 2026 (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 trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: trastuzumab, Drug: bevacizumab |
| Treatment group B | Other | Drug: bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants voluntarily join this trial and sign an informed consent form.
- Newly diagnosed stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by histological or cytological pathology.
- Prior to first-line platinum-based doublet chemotherapy combined with bevacizumab.
- No disease progression as assessed by the investigator after completion of first-line platinum-based therapy and before randomization.
- Participants' homologous recombination deficiency test results must meet the criteria.
Key exclusion criteria (16 listed)
- Participants with untreated or active central nervous system (CNS) metastases; a history of meningeal metastases or current meningeal metastases.
- Participants with clinically symptomatic, poorly controlled, or moderate to severe pleural effusion, pericardial effusion, or ascites.
- Participants with a history of or concurrent other malignancies, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥5 years prior to randomization with evidence of no recurrence or metastasis.
- Participants with a history of interstitial pneumonia/interstitial lung disease requiring steroid treatment, non-infectious pneumonia (such as radiation pneumonitis), current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonia, or other active pneumonia; or those with severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or other lung damage within 6 months prior to randomization.
- 6. Individuals with active pulmonary tuberculosis; those who have received adequate and regular treatment and have stopped anti-tuberculosis treatment for ≥3 months prior to randomization are eligible for enrollment.
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 |
|---|---|---|
| trastuzumabtrastuzumab | Drug | Treatment group A |
| bevacizumabbevacizumab | Drug | Treatment group A, Treatment group B |
Primary outcome
Dose limited toxicity (DLT)
Time frame: up to 21 days
Progression Free Survival (PFS)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
11 secondary outcomes
AEs+SAEs
Time frame: from the first drug administration to within 40 days for the last treatment dose
Ctrough
Time frame: from the first drug administration to within 40 days for the last treatment dose
ADA
Time frame: from the first drug administration to within 40 days for the last treatment dose
Overall survival (OS)
Time frame: Approximately 3 years after last subject enrolled
Second progression-free survival (PFS2)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Objective Response Rate (ORR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Disease Control Rate (DCR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Duration of Response (DoR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to disease progression (TTP)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Cancer antigen-125 response rate (CA-125 RR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to the start of subsequent treatment (TFST)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trastuzumab and bevacizumab in people with Ovarian Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 3 sites 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 11 inclusion and 16 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Shuni Wang, M.D (+86-0518-81220121, shuni.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) (time frame: up to 21 days). The study lists 2 primary outcomes in all. 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 4 Nov 2026.