Benmelstobart in Combination With Anlotinib and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial OvariaN, Fallopian Tube, or Primary Peritoneal 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: Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer. Basic parameters: from 18 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
- Center list to be confirmed — check the primary protocol.
- 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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Overview
Efficacy and safety of Benmelstobart combined with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (BACON study) in China
Interventions
- Drug Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide
Benmelstobart in combination with Anlotinib and oral metronomic Cyclophosphamide in the treatment of recurrent epithelial OvariaN, fallopian tube, or primary peritoneal cancer
Primary outcome measures
- progression-free survival (PFS) [Time frame: from enrollment to the end of treatment at 2 years]
Secondary outcome measures (3)
- CRR [Time frame: 6 months]
- OS [Time frame: 5 years]
- AEs [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 1.The age on the day of signing the informed consent form is 18 years or older. 2.Eastern Cooperative Oncology Group performance status of 0-1, with the ability to tolerate chemotherapy.
3.There is measurable disease according to the RECIST 1.1 or irRECIST criteria. 4.The histological types can be serous, endometrioid, clear cell, mucinous or undifferentialed types of recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. The original primary tumor needs to be histologically confirmed through the pathological report.
5.Participants can be either platinum-sensitive (with a platinum-free interval(PFI) of ≥6 months before the recent recurrence) or platinum-resistant (with a PFI of <6 months before the recent recurrence). If the participant has a platinum-sensitive disease, they can only participate in this clinical trial with platinum-based chemotherapy contraindications (such as severe persistent toxicity or a severe hypersensitivity reaction to platinum drugs, or refuse standard treatment).
6.The participants must be willing to undergo hollow needle biopsy or excisional biopsy of tumor lesion within 4 weeks (28 days) before the start of the treatment and after 3 cycles treatment. For participants who are unable to provide new samples (for example, unable to obtain or there are issues related to the safety of the participants), only with the consent of the principal investigator can archived samples be submitted.
Exclusion criteria
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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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07489300 · BACON study