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This study is a single-arm, open-label, multicenter, exploratory clinical trial aimed at observing and evaluating the efficacy and safety of camrelizumab combined with famitinib in the adjuvant treatment of cervical cancer patients after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| camrelizumab combined with famotinib | Experimental | Camrelizumab combined with famitinib for adjuvant therapy after radical resection of cervical cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg, intravenous drip for 0.5h, Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year disease-free survival rate | The proportion of cancer patients without recurrence, metastasis, or tumor-related death within 2 years after treatment, for evaluating short-term efficacy. | 2 years after treatment |
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Inclusion Criteria:
Age: 18-75 years old, female;
No prior systemic anti-tumor treatment (including chemotherapy, radiotherapy, or other investigational treatments);
PD-L1 test result: CPS ≥ 1;
Presence of measurable lesions at baseline according to RECIST 1.1 criteria;
Pathological types: squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma;
FIGO 2018 stage: IA, IB1-2, IIA1, IB3, IIA2;
ECOG PS: 0-1;
Expected survival period > 3 months;
Good function of major organs, meeting the following criteria:
Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before enrollment must be negative, and they must be non-lactating patients; male patients must agree to use contraceptive measures during the study and within 6 months after the end of the study;
Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Li Doctor | Contact | fudanlijin@163.com | fudanlijin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
Data is available per require after approved by ethics broad
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| famotinib |
| Drug |
10mg, oral administration, QD |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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