Ovarian CancerPhase 2NCT07285941
Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment
A Phase 2 study testing RC48 + Carboplatin in people with Ovarian Cancer and HER2, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, HER2
- What is being tested?
- RC48 + Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2025to 31 Jan 2028
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;
- Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;
- HER2 expression: IHC 2+ or 3+;
- Had not received chemotherapy before enrollment;
- ECOG PS ≤ 2;
- Expected survival period ≥ 3 months;
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- Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula;
- Non-pregnant women;
- Signed a written informed consent form before the trial.
Who cannot join
- Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);
- The subject had central nervous system diseases or brain metastases;
- Had previously experienced grade II or above peripheral neuropathy;
- Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);
- Had known allergies to the study-related drugs or their excipients or was intolerant to them;
- Was participating in other clinical trials at the same time;
- Subjects judged by the researcher to be unsuitable for this 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, 1 recruiting
- Recruiting
Zhe Jiang Cancer Hospital
Zhejiang, Zhejiang, 310000
Shao, +86 13486127234, shaozy@zjcc.org.cn
About this study
Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. However, conventional paclitaxel, due to the addition of polyoxyethylated castor oil solubilizer, may induce various adverse reactions beyond chemotherapeutic toxicity, such as hypersensitivity, toxic renal injury, neurotoxicity, and cardiovascular toxicity. Therefore, exploring optimized treatment regimens to provide patients with new therapeutic options is imperative.
HER2 is a protein encoded by the ERBB2 gene that regulates cell survival, proliferation, and differentiation. HER2 gene amplification and/or protein overexpression are observed in 18%-35% of mucinous ovarian cancers. A meta-analysis involving over 5,000 ovarian cancer cases revealed that HER2 overexpression correlates with reduced overall survival (OS) and progression-free survival (PFS), suggesting its potential as a biomarker for poor prognosis.
Read more
The emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48). Preliminary results from the PRaG3.0 trial presented at the 2023 ASCO Annual Meeting showed an ORR of 66.7% in six HER2-expressing gynecological cancer patients treated with RC48 combined with radiotherapy and immune checkpoint inhibitors (ICIs). Updated data from the RC48-C018 study demonstrated an ORR of 36.4%, median duration of response (mDoR) of 5.52 months, mPFS of 4.37 months, and 12-month OS rate of 66% in 22 cervical cancer patients. RC48 exhibited promising efficacy and manageable safety in recurrent/metastatic HER2-expressing (IHC 1+/2+/3+) cervical cancer.
Regarding safety, the GOG-158 study reported pronounced hematologic toxicity with carboplatin-paclitaxel in advanced ovarian cancer: grade 3/4 leukopenia (>50%), thrombocytopenia (>30%), and neutropenia (>80%). Conversely, a retrospective study of RC48 combined with platinum ± bevacizumab in HER2-mutated NSCLC patients showed an ORR of 71.4% with no dose reductions or discontinuations due to adverse events. Thus, RC48-platinum combinations may offer a lower-toxicity alternative. Thus the investigators designed this trial to evaluate the efficacy and safety of RC48 combined with carboplatin in HER2-expressing advanced ovarian cancer.
- Conditions
- Ovarian Cancer, HER2
- Being tested
- RC48 + Carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48 + CarboplatinDrug
RC48, 2.5 mg/kg, on day 1, every 3 weeks; Carboplatin, AUC 5-6, on day 1, every 3 weeks; q3w, with a maximum of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | RC48, 2.5 mg/kg, on day 1, every 3 weeks; Carboplatin, AUC 5-6, on day 1, every 3 weeks; q3w, with a maximum of 6 cycles. Receives: Drug: RC48 + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
The length of time from the start of treatment (or randomisation in a clinical trial) until the disease progresses or the patient dies from any cause, whichever occurs first.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Objective Response Rate
The percentage of subjects who achieved the best response (CR or PR) during the period from the start of the treatment regimen in this study until the onset of disease progression and were excluded from the study, in relation to the total number of subjects in the analyzed dataset.
Measured: up to 12 weeks
overall survival
It refers to the period from a randomly selected date to the date of death due to any cause.
Measured: through study completion, an average of 5 year
adverse events
Incidence rate of adverse reaction events
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start4 Jan 2025
- Primary completion4 Jan 2027 (estimated)
- Study completion31 Jan 2028 (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 Zhejiang Cancer HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShaoZhuyan, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285941
- Sponsor's protocol ID
- RCVDTYPEC100
- Status last verified
- Jan 2025
- First submitted
- 29 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment
- ClinicalTrials.gov ID
- NCT07285941
- Acronym / sponsor ID
- RCVDTYPEC100
- Conditions
- Ovarian Cancer, HER2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 16 Dec 2025 (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.
Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. However, conventional paclitaxel, due to the addition of polyoxyethylated castor oil solubilizer, may induce various adverse reactions beyond chemotherapeutic toxicity, such as hypersensitivity, toxic renal injury, neurotoxicity, and cardiovascular toxicity. Therefore, exploring optimized treatment regimens to provide patients with new therapeutic options is imperative.
HER2 is a protein encoded by the ERBB2 gene that regulates cell survival, proliferation, and differentiation. HER2 gene amplification and/or protein overexpression are observed in 18%-35% of mucinous ovarian cancers. A meta-analysis involving over 5,000 ovarian cancer cases revealed that HER2 overexpression correlates with reduced overall survival (OS) and progression-free survival (PFS), suggesting its potential as a biomarker for poor prognosis.
The emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48). Preliminary results from the PRaG3.0 trial presented at the 2023 ASCO Annual Meeting showed an ORR of 66.7% in six HER2-expressing gynecological cancer patients treated with RC48 combined with radiotherapy and immune checkpoint inhibitors (ICIs). Updated data from the RC48-C018 study demonstrated an ORR of 36.4%, median duration of response (mDoR) of 5.52 months, mPFS of 4.37 months, and 12-month OS rate of 66% in 22 cervical cancer patients. RC48 exhibited promising efficacy and manageable safety in recurrent/metastatic HER2-expressing (IHC 1+/2+/3+) cervical cancer.
Regarding safety, the GOG-158 study reported pronounced hematologic toxicity with carboplatin-paclitaxel in advanced ovarian cancer: grade 3/4 leukopenia (>50%), thrombocytopenia (>30%), and neutropenia (>80%). Conversely, a retrospective study of RC48 combined with platinum ± bevacizumab in HER2-mutated NSCLC patients showed an ORR of 71.4% with no dose reductions or discontinuations due to adverse events. Thus, RC48-platinum combinations may offer a lower-toxicity alternative. Thus the investigators designed this trial to evaluate the efficacy and safety of RC48 combined with carboplatin in HER2-expressing advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: RC48 + CarboplatinRC48, 2.5 mg/kg, on day 1, every 3 weeks; Carboplatin, AUC 5-6, on day 1, every 3 weeks; q3w, with a maximum of 6 cycles. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;
- Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;
- HER2 expression: IHC 2+ or 3+;
- Had not received chemotherapy before enrollment;
- ECOG PS ≤ 2;
Key exclusion criteria (8 listed)
- Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);
- The subject had central nervous system diseases or brain metastases;
- Had previously experienced grade II or above peripheral neuropathy;
- Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);
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 |
|---|---|---|
| RC48 + CarboplatinRC48, 2.5 mg/kg, on day 1, every 3 weeks; Carboplatin, AUC 5-6, on day 1, every 3 weeks; q3w, with a maximum of 6 cycles. | Drug | experimental group |
Primary outcome
progression free survival
Time frame: through study completion, an average of 1 year
The length of time from the start of treatment (or randomisation in a clinical trial) until the disease progresses or the patient dies from any cause, whichever occurs first.
3 secondary outcomes
Objective Response Rate
Time frame: up to 12 weeks
overall survival
Time frame: through study completion, an average of 5 year
adverse events
Time frame: through study completion, an average of 5 year
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 16 Dec 2025.
- Individual participant dataSharing planned: No. To protect participant privacy and confidentiality
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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 RC48 + Carboplatin in people with Ovarian Cancer and HER2, run by Zhejiang Cancer Hospital 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 9 inclusion and 8 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 16 Dec 2025. 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 Shao (+8613486127234, shaozy@zjcc.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 (time frame: through study completion, an average of 1 year). 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 16 Dec 2025.