Recruiting NCT06840002
A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811, Carboplatin, Bevacizumab, Oxaliplatin for Injection.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
Overview
The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.
Interventions
- Drug SHR-A1811
SHR-A1811. - Drug Carboplatin
Carboplatin. - Drug Bevacizumab
Bevacizumab. - Drug Oxaliplatin for Injection
Oxaliplatin for injection. - Drug Paclitaxel injection
Paclitaxel injection. - Drug Doxorubicin hydrochloride liposome injection
Doxorubicin hydrochloride liposome injetction. - Drug Adebrelimab Injection
Adebrelimab injection.
Primary outcome measures
- Dose limited toxicity (DLT) [Time frame: Up to 21 days.]
- Recommended phase II dose (RP2D) [Time frame: Up to 21 days.]
- Objective response rate (ORR) [Time frame: Every 9 weeks lasting about one year.]
Secondary outcome measures (7)
- Duration of response (DoR) [Time frame: Every 9 weeks lasting about one year.]
- Disease control rate (DCR) [Time frame: Every 9 weeks lasting about one year.]
- Progression free survival (PFS) [Time frame: Every 9 weeks lasting about one year.]
- Standard response rate (RR) [Time frame: Every 9 weeks lasting about one year.]
- Overall survival (OS) [Time frame: Approximately 3 years after the last subject enrolled.]
- Adverse events (AEs) [Time frame: From the first drug administration to within 90 days after the last dose.]
- Serious adverse events (SAEs) [Time frame: From the first drug administration to within 90 days after the last dose.]
Eligibility criteria
Inclusion criteria
- Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
- Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
- At least one measurable lesion conforming to RECIST v1.1.
- ECOG PS score: 0-1.
- Expected survival ≥ 12 weeks.
- Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.
Exclusion criteria
- With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
- Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
- Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
- With hypertension and cannot be well controlled by antihypertensive drug treatment.
- Accompanied by poorly controlled or serious cardiovascular diseases.
- Subjects with serious infection within 1 month before the first medication.
- Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
- There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and T — Wuhan
Identifiers
NCT: NCT06840002 · SHR-A1811-216-OC