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RecruitingNCT07779538Updated Nov 4, 2026

Clinical Trials Comparing Trastuzumab Plus Bevacizumab With Bevacizumab as First-line Maintenance Therapy for Epithelial Ovarian Cancer

A Phase 3 interventional study of trastuzumab and bevacizumab in Ovarian Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 3 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment

Updated Nov 4, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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 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.

02

Conditions studied

  • Ovarian Cancer

Browse trials for

03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 420 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 104 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants voluntarily join this trial and sign an 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 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. 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 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 from the date of signing the informed consent form until 7 months after the last dose.

Exclusion criteria

Exclusion Criteria:

  1. Participants with untreated or active central nervous system (CNS) ; 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 , 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 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 (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 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 (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 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.

Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    Drug: trastuzumab · Drug: bevacizumab

  • Other
    Treatment group B

    Drug: bevacizumab

Interventions

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What researchers measure

Primary outcomes

  1. Dose limited toxicity (DLT)

    Time frame: up to 21 days

  2. Progression Free Survival (PFS)

    Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years

Secondary outcomes

  1. AEs+SAEs

    Time frame: from the first drug administration to within 40 days for the last treatment dose

  2. Ctrough

    Time frame: from the first drug administration to within 40 days for the last treatment dose

  3. ADA

    Time frame: from the first drug administration to within 40 days for the last treatment dose

  4. Overall survival (OS)

    Time frame: Approximately 3 years after last subject enrolled

  5. Second progression-free survival (PFS2)

    Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years

  6. Objective Response Rate (ORR)

    Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years

  7. Disease Control Rate (DCR)

    Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years

  8. Duration of Response (DoR)

    Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years

  9. Time to disease progression (TTP)

    Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years

  10. 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

  11. 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

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Study locations

3 of 3 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Feb 2030, 40 months after the start.

Of 73 industry-sponsored phase 3 interventional studies under Ovarian Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 72. This study's planned 40 months is below that.

Counting every sponsor, half of 125 studies reached it within 59 months; a quarter within 37 and three quarters within 89.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2026
First posted
Aug 21, 2026
StartActual
Oct 20, 2026was Sep 2026
Primary completionEst.
Feb 28, 2030
CompletionEst.
May 30, 2030
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 4, 2026
Sites
3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • Cancer Hospital Chinese Academy of Medical Sciences · Beijing, Chinano status→Recruiting
  • Zhejiang Cancer Hospital · Zhejiang, Chinano status→Recruiting
  • Yunnan Cancer Hospital · Yunnan, Chinano status→Recruiting
Nov 4, 2026
Start date
Sep 1, 2026→Oct 20, 2026 (actual)
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Not yet recruiting→Recruiting
    3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Cancer Hospital Chinese Academy of Medical Sciences · Beijing, Chinano status→Recruiting
    • Zhejiang Cancer Hospital · Zhejiang, Chinano status→Recruiting
    • Yunnan Cancer Hospital · Yunnan, Chinano status→Recruiting
    Start date Sep 1, 2026→Oct 20, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07779538
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Oct 20, 2026
Primary completion
Feb 28, 2030 (estimated)
Completion
May 30, 2030 (estimated)
Last update
Nov 4, 2026

Study contacts

Shuni Wang, M.D
Contact
shuni.wang@hengrui.com
+86-0518-81220121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Trastuzumab

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