Clinical trial Recruiting at 3 sites Phase 3 Interventional Ages 18 and up Women only

Trastuzumab plus bevacizumab vs bevacizumab alone as first-line maintenance therapy for ovarian cancer

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

Run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · NCT07779538 · Data updated 2026-11-12

This trial tests whether adding trastuzumab to bevacizumab maintenance helps people with epithelial ovarian cancer after initial platinum-based therapy.

More Ovarian Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment420 (estimated)
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy, radiation
Locations3 sites (Beijing, Beijing Municipality and 2 other locations)
StatusRecruiting
StartedOctober 20, 2026
Main results expectedFebruary 28, 2030
Study endsMay 30, 2030
Registry record updatedNovember 4, 2026
Trial IDNCT07779538 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with newly diagnosed stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who completed first-line platinum-based therapy with bevacizumab and have no progression.

Probably not a fit

Patients without HER2 expression/eligibility, or those who progress during maintenance, may not benefit from the trastuzumab-containing approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized phase III trial with an initial safety run-in (phase Ib) followed by efficacy evaluation (phase III). It compares SHR-A1811 plus bevacizumab against bevacizumab alone as maintenance therapy in patients who have not shown disease progression after first-line platinum-based triple therapy. Participants have advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer and meet specific biomarker and performance status criteria. The study includes a central lab for tissue testing and evaluates safety, tolerability, and efficacy endpoints. Enrollment spans three cancer centers in China, with open-label treatment and positive-control design.

Why it matters

Potential benefit: If successful, patients may experience prolonged disease control and potential survival benefits with a trastuzumab-containing maintenance strategy.

How similar studies have gone: Prior approaches adding targeted monoclonal antibodies to maintenance regimens have shown potential in select ovarian cancer subgroups, but this specific combination is under evaluation for benefit.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Participants voluntarily join this trial and sign an informed consent form.
2. Newly diagnosed stage III or IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, confirmed by histological or cytological pathology.
3. Prior to first-line platinum-based doublet chemotherapy combined with bevacizumab.
4. No disease progression as assessed by the investigator after completion of first-line platinum-based therapy and before randomization.
5. Participants' homologous recombination deficiency test results must meet the criteria.
6. Participants have not received any anti-tumor therapy from the last dose of first-line platinum-based therapy until randomization.
7. Able to provide sufficient fresh or archived tumor tissue specimens for testing at the sponsor-designated central laboratory.
8. ECOG PS score: 0-1.
9. Expected survival ≥ 12 weeks.
10. Laboratory tests within 7 days prior to randomization confirm that important organ function meets the requirements.
11. 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.

Exclusion Criteria:

1. Participants with untreated or active central nervous system (CNS) metastases; a history of meningeal metastases or current meningeal metastases.
2. Participants with clinically symptomatic, poorly controlled, or moderate to severe pleural effusion, pericardial effusion, or ascites.
3. 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.
4. 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.
5. 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.

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.

Where it's running

  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
    Recruiting
  • Zhejiang Cancer Hospital
    Zhejiang, Hangzhou, China
    Recruiting
  • Yunnan Cancer Hospital
    Yunnan, Kunming, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.