SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical 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, Adebelimab injection, Bevacizumab injection, SHR-8068.
- Who it may be relevant to
- Registry conditions: Recurrent or Metastatic Cervical 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
Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
Overview
This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
Interventions
- Drug SHR-A1811
SHR-A1811 injection. - Drug Adebelimab injection
Adebelimab injection. - Drug Bevacizumab injection
Bevacizumab injection. - Drug SHR-8068
SHR-8068 injection. - Drug Cisplatin injection
Cisplatin injection. - Drug Carboplatin injection
Carboplatin injection.
Primary outcome measures
- Grade≥3 drug-related adverse events (TRAEs). [Time frame: Up to 3 years.]
- Grade≥3 drug-related serious adverse events (TRAEs). [Time frame: Up to 3 years.]
- Objective response rate (ORR). [Time frame: Up to 3 years.]
Secondary outcome measures (4)
- Duration of response (DOR). [Time frame: Up to 3 years.]
- Disease control rate (DCR). [Time frame: Up to 3 years.]
- Progression-free survival (PFS). [Time frame: Up to 3 years.]
- Overall survival (OS). [Time frame: Up to 3 years.]
Eligibility criteria
Inclusion criteria
- Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
- Female, aged 18-75 years old.
- Expected survival ≥ 12 weeks.
- Normal function of vital organs.
- Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
- Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.
Exclusion criteria
- Previous or concomitant other malignancies.
- Severe bone damage caused by bone metastasis from tumours.
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
- Those with active tuberculosis.
- Concomitant poorly controlled or severe cardiovascular disease.
- Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
- Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
- Subjects who have had a serious infection within 1 month before the first dose.
- Subjects who have a history of immunodeficiency.
- As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06859775 · SHR-A1811-216-CC