Ovarian CancerPhase 2NCT07776171
Trastuzumab Rezetecan and Carboplatin ± Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer
A Phase 2 study testing Trastuzumab Rezetecan (SHR-A1811), Carboplatin and Bevacizumab in people with Ovarian Cancer and Platinum Sensitive Ovarian Cancer (PSOC), run by Sun Yat-sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, Platinum Sensitive Ovarian Cancer (PSOC)
- What is being tested?
- Trastuzumab Rezetecan (SHR-A1811), Carboplatin and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 May 2030
- Phase
- Phase 2
- 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
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.
- Aged 18 to 75 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- 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).
- Must have received prior treatment with a PARP inhibitor.
- Able to provide sufficient fresh or archival tumor tissue specimens for detection of HER2 expression levels.
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- Have at least one measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival of more than 3 months.
- Adequate major organ function.
- Subjects of childbearing potential must use at least one medically approved contraceptive 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.
Who cannot join
- Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.
- Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.
- Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.
- Untreated or active central nervous system (CNS) metastases.
- Prior history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required steroid treatment; current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonitis, or other active pneumonitis.
- Active ulcer, intestinal perforation, or intestinal obstruction.
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- Known hereditary or acquired bleeding disorders (e.g., coagulation dysfunction, hemophilia) or thrombotic tendency.
- Toxicity from prior anti-tumor therapy that has not recovered to ≤ Grade 1 per NCI-CTCAE v6.0.
- 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.
- Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
- Uncontrolled or severe cardiovascular disease, such as unstable angina, symptomatic congestive heart failure (NYHA 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.
- 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.
- Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate interventions.
- Severe infection within 1 month before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, or severe pneumonia.
- Concurrent or previous other malignancies, 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.
- History of immunodeficiency (including HIV-positive test), other acquired or congenital immunodeficiency diseases, or history of organ transplantation; known active hepatitis B (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 hepatitis C (defined as positive hepatitis C virus antibody [HCV-Ab] and positive HCV-RNA at screening).
- Any clinical or laboratory abnormality or other reason that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Chunyan Lan, +862087343870, lanchy@sysucc.org.cn
About this study
Official title: Trastuzumab Rezetecan and Carboplatin With or Without Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer: an Open-label, Multicenter, Randomized Controlled Phase II Study
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).
- Being tested
- Trastuzumab Rezetecan (SHR-A1811), Carboplatin, Bevacizumab, Carboplatin + Paclitaxel, Carboplatin + pegylated liposomal doxorubicin
- Keywords
- Ovarian cancer, Epithelial Ovarian Cancer, Platinum-sensitive recurrent ovarian cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan (SHR-A1811)Drug
Administered intravenously on Day 1 of each 3-week treatment cycle.
CarboplatinDrug
Administered intravenously on Day 1 of each 3-week treatment cycle.
BevacizumabDrug
Administered intravenously on Day 1 of each 3-week treatment cycle.
BevacizumabDrug
Administered intravenously.
Carboplatin + PaclitaxelDrug
Administered intravenously.
Carboplatin + pegylated liposomal doxorubicinDrug
Administered intravenously.
Carboplatin + GemcitabineDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab rezetecan + Carboplatin ± Bevacizumab | Experimental | Participants will receive trastuzumab rezetecan + carboplatin ± bevacizumab once every 3 weeks (Q3W). Receives: Drug: Trastuzumab Rezetecan (SHR-A1811); Drug: Carboplatin; Drug: Bevacizumab |
| Investigator Choice of Chemotherapy ± Bevacizumab | Active comparator | Participants will receive carboplatin plus paclitaxel ± bevacizumab, carboplatin plus gemcitabine ± bevacizumab, , or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab. Receives: Drug: Bevacizumab; Drug: Carboplatin + Paclitaxel; Drug: Carboplatin + pegylated liposomal doxorubicin; Drug: Carboplatin + Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as determined by investigators.
Measured: Up to approximately 3 years
Secondary outcomes (6)
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.
Measured: Up to approximately 3 years
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).
Measured: Up to approximately 3 years
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.
Measured: Up to approximately 3 years
Overall Survival (OS)
Defined as the time from the randomization date to death due to any cause in subjects.
Measured: Up to approximately 5 years
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
Measured: Up to approximately 3 years
Quality of life: EQ-5D-5L Questionnaire
Overall change from baseline scores in quality of life by cycle and between treatment arms.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (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 Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Lan，MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776171
- Sponsor's protocol ID
- MA-OC-II-018
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Rezetecan and Carboplatin With or Without Bevacizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-sensitive Recurrent Ovarian Cancer: an Open-label, Multicenter, Randomized Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT07776171
- Acronym / sponsor ID
- MA-OC-II-018
- Keywords
- Ovarian cancer, Epithelial Ovarian Cancer, Platinum-sensitive recurrent ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 20 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab rezetecan + Carboplatin ± Bevacizumab | Experimental | Drug: Trastuzumab Rezetecan (SHR-A1811), Drug: Carboplatin, Drug: BevacizumabParticipants will receive trastuzumab rezetecan + carboplatin ± bevacizumab once every 3 weeks (Q3W). |
| Investigator Choice of Chemotherapy ± Bevacizumab | Active comparator | Drug: Bevacizumab, Drug: Carboplatin + Paclitaxel, Drug: Carboplatin + pegylated liposomal doxorubicin, Drug: Carboplatin + GemcitabineParticipants will receive carboplatin plus paclitaxel ± bevacizumab, carboplatin plus gemcitabine ± bevacizumab, , or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.
- Aged 18 to 75 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- 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).
- Must have received prior treatment with a PARP inhibitor.
Key exclusion criteria (17 listed)
- Ovarian cancer with pathological types of clear cell carcinoma, low-grade serous adenocarcinoma, or mucinous adenocarcinoma.
- Known allergy to any component of trastuzumab rezetecan; known allergy to carboplatin.
- Prior treatment with anti-HER2 therapy, an antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor, or a topoisomerase I inhibitor alone.
- Untreated or active central nervous system (CNS) metastases.
- Prior history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required steroid treatment; current or suspected interstitial pneumonia/interstitial lung disease, non-infectious pneumonitis, or other active pneumonitis.
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 |
|---|---|---|
| Trastuzumab Rezetecan (SHR-A1811)Administered intravenously on Day 1 of each 3-week treatment cycle. | Drug | Trastuzumab rezetecan + Carboplatin ± Bevacizumab |
| CarboplatinAdministered intravenously on Day 1 of each 3-week treatment cycle. | Drug | Trastuzumab rezetecan + Carboplatin ± Bevacizumab |
| BevacizumabAdministered intravenously on Day 1 of each 3-week treatment cycle. | Drug | Trastuzumab rezetecan + Carboplatin ± Bevacizumab |
| BevacizumabAdministered intravenously. | Drug | Investigator Choice of Chemotherapy ± Bevacizumab |
| Carboplatin + PaclitaxelAdministered intravenously. | Drug | Investigator Choice of Chemotherapy ± Bevacizumab |
| Carboplatin + pegylated liposomal doxorubicinAdministered intravenously. | Drug | Investigator Choice of Chemotherapy ± Bevacizumab |
| Carboplatin + GemcitabineAdministered intravenously | Drug | Investigator Choice of Chemotherapy ± Bevacizumab |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as determined by investigators.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
Disease Control Rate (DCR)
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Quality of life: EQ-5D-5L Questionnaire
Time frame: Up to approximately 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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezetecan (SHR-A1811), Carboplatin and Bevacizumab in people with Ovarian Cancer and Platinum Sensitive Ovarian Cancer (PSOC), run by Sun Yat-sen University 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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 20 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chunyan Lan Prof. (+862087343870, lanchy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to approximately 3 years). 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 20 Aug 2026.