Fallopian Tube Cancers, Ovarian Cancer, Primary Peritoneal Cancer
Conditions
Keywords
Benmelstobart, Anlotinib, oral metronomic Cyclophosphamide, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer
Brief summary
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
DRUGBenmelstobart 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
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | from enrollment to the end of treatment at 2 years | 24 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRR | 6 months | The objective response rate is evaluated simultaneously by using the RECIST1.1 criteria (Response Evaluation Criteria for solid Tumors) and the immune-related Response Criteria (irRECIST). |
| OS | 5 years | OS is defined as the time from the date of randomization until death |
| AEs | 12 months | Proportion of patients with grade 3 or more treatment-related adverse events(except hematologic toxicity) graded by CTCAE v5 |
Outcome results
None listed