ClinicalTrials.gg
Not yet recruitingNCT07776171Updated Aug 20, 2026

Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer

A Phase 2 interventional study of Trastuzumab Rezetecan (SHR-A1811) and Carboplatin in Ovarian Cancer and Platinum Sensitive Ovarian Cancer (PSOC), sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 166 studies testing carboplatin in Ovarian Neoplasms — 14 open to participants now, 21 under way, 6 of them phase 3. Carboplatin · Ovarian Neoplasms.

Planned enrollment
25th of 150
176 · median 48
Started
2026
with 2 others
Phase 2
84 of 166
8 open now
Primary completion
2028-03
later than 17 of 20 live
Registered
166th of 166
by date

Among the 166 studies testing carboplatin in Ovarian Neoplasms, this one is the 25th largest by planned enrollment of the 150 interventional ones that give a count, is one of 3 that started in 2026, is one of 84 in phase 2, reaches primary completion later than 17 of the 20 other live ones, and was the 166th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

14 of the 166 studies testing carboplatin in Ovarian Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

8 more — sign in →

By country, each count listing its studies:

All 14 open studies →

About carboplatin

Carboplatin: first FDA approval 1989 (PARAPLATIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years to 75 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 166 studies testing carboplatin in Ovarian Neoplasms, or all of them as a file.
02

Study summary

This study is a randomized, open-label, controlled phase II clinical trial.

It is planned to enroll 176 subjects with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer previously treated with Poly (ADP-ribose) polymerase inhibitors (PARPi).

Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (trastuzumab Rezetecan + carboplatin ± bevacizumab) or the control treatment group (investigator's choice chemotherapy ± bevacizumab).

03

Conditions studied

  • Ovarian Cancer
  • Platinum Sensitive Ovarian Cancer (PSOC)

Keywords

  • Ovarian cancer
  • Epithelial Ovarian Cancer
  • Platinum-sensitive recurrent ovarian cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
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. Subjects voluntarily participate in this study, sign the form, and have good compliance.
  2. Aged 18 to 75 years.
  3. confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
  4. Have received 1-3 prior lines of platinum-based chemotherapy and have experienced disease progression or recurrence ≥6 months after the last platinum-based treatment (platinum-sensitive relapse).
  5. Must have received prior treatment with a PARP inhibitor.
  6. Able to provide sufficient fresh or specimens for detection of expression levels.
  7. Have at least one per v1.1.
  8. (ECOG) performance status of 0-1.
  9. Expected survival of more than 3 months.
  10. Adequate major organ function.
  11. Subjects of must use at least one medically approved measure (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 180 days after the end of study treatment; must have a negative serum/urine HCG test before the first dose; and must not be breastfeeding.

Exclusion criteria

Exclusion Criteria:

  1. Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.
  2. Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.
  3. Prior treatment with anti- therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.
  4. Untreated or active central nervous system (CNS) .
  5. Prior history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required treatment; current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonitis, or other active pneumonitis.
  6. Active ulcer, intestinal perforation, or intestinal obstruction.
  7. Known hereditary or acquired bleeding disorders (e.g., coagulation dysfunction, hemophilia) or thrombotic tendency.
  8. Toxicity from prior anti-tumor therapy that has not recovered to ≤ Grade 1 per v6.0.
  9. Arterial/venous thrombotic events (including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism) within 6 months before the first dose; however, if muscular venous thrombosis or catheter-related thrombosis associated with an infusion port is present before the first dose and the investigator deems it to be without risk, the subject may be enrolled.
  10. Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
  11. Uncontrolled or severe cardiovascular disease, such as unstable angina, symptomatic congestive heart failure ( class II-IV), myocardial infarction within 6 months before the first dose, or unstable angina or unstable arrhythmia within 1 month before the first dose.
  12. Prior surgery, radical radiotherapy, chemotherapy, macromolecular targeted therapy, or anti-tumor immunotherapy with completion (last dose) less than 4 weeks before the first dose; prior small-molecule targeted drugs with last dose less than 5 half-lives or 4 weeks (whichever is shorter) before the first dose; prior palliative radiotherapy or local therapy with completion less than 2 weeks before the first dose.
  13. Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate interventions.
  14. Severe infection within 1 month before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia.
  15. Concurrent or previous other , except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years with documented evidence of no recurrence or metastasis.
  16. History of immunodeficiency (including -positive test), other acquired or congenital immunodeficiency diseases, or history of organ transplantation; known active (defined as HBsAg-positive with HBV DNA ≥500 IU/mL [or ≥2500 copies/mL if the study site only uses copies/mL, in which case the subject is not eligible]) or active (defined as positive hepatitis C virus antibody [HCV-Ab] and positive HCV-RNA at screening).
  17. Any clinical or laboratory abnormality or other reason that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.
Terms in these criteria, in plain language(17)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

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.

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.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
176 participants (estimated)

Study arms

  • Experimental
    Trastuzumab rezetecan + Carboplatin ± Bevacizumab

    Participants will receive trastuzumab rezetecan + carboplatin ± bevacizumab once every 3 weeks (Q3W).

    Drug: Trastuzumab Rezetecan (SHR-A1811) · Drug: Carboplatin · Drug: Bevacizumab

  • Active comparator
    Investigator Choice of Chemotherapy ± Bevacizumab

    Participants will receive carboplatin plus paclitaxel ± bevacizumab, carboplatin plus gemcitabine ± bevacizumab, , or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.

    Drug: Bevacizumab · Drug: Carboplatin + Paclitaxel · Drug: Carboplatin + pegylated liposomal doxorubicin · Drug: Carboplatin + Gemcitabine

Interventions

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as determined by investigators.

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Defined as the proportion of subjects who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). For responses categorized as CR or PR, confirmation is required through a subsequent evaluation performed no less than 4 weeks (≥28 days) after the initial assessment.

    Time frame: Up to approximately 3 years

  2. Disease Control Rate (DCR)

    Defined as the proportion of subjects with a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Time frame: Up to approximately 3 years

  3. Duration of Response (DoR)

    Defined as the time from the first date a subject is assessed as having a confirmed Complete Response (CR) or Partial Response (PR) to the first date of either Progressive Disease (PD) or death due to any cause, whichever occurs first.

    Time frame: Up to approximately 3 years

  4. Overall Survival (OS)

    Defined as the time from the randomization date to death due to any cause in subjects.

    Time frame: Up to approximately 5 years

  5. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Number of patients experiencing any grade and grade 3-4 toxicity for each toxicity according to NCI-CTCAE v6.0

    Time frame: Up to approximately 3 years

  6. Quality of life: EQ-5D-5L Questionnaire

    Overall change from baseline scores in quality of life by cycle and between treatment arms.

    Time frame: Up to approximately 3 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar 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

Start is estimated for Sep 2026; primary completion for Mar 2028, 18 months later.

Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 18 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

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

Registered
Aug 17, 2026
First posted
Aug 20, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Mar 30, 2028
CompletionEst.
May 30, 2030
Last update
Aug 20, 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.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776171
Responsible party
Chunyan Lan,MD (Prof., Sun Yat-sen University) — Principal investigator
First posted
Aug 20, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 30, 2028 (estimated)
Completion
May 30, 2030 (estimated)
Last update
Aug 20, 2026

Study contacts

Chunyan Lan Prof.
Contact
lanchy@sysucc.org.cn
+862087343870

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Trastuzumab rezetecan · Carboplatin

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