A Single-arm, Multicenter, Phase II Clinical Study of Camrelizumab Combined With Famitinib in Adjuvant Therapy After Radical Resection of Cervical Cancer

Обзор

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.

Вмешательства

• Препарат Camrelizumab
  200mg, intravenous drip for 0.5h, Q3W
• Препарат famotinib
  10mg, oral administration, QD

Первичные конечные точки

• 2-year disease-free survival rate [Срок оценки: 2 years after treatment]

Критерии участия

Критерии включения

• 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:

• Blood routine examination (without blood transfusion or use of hematopoietic stimulating factors to correct the condition within 14 days): hemoglobin (Hb) ≥ 90g/L; absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelets (PLT) ≥ 90×10⁹/L;
• Biochemical examination: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (for patients with liver metastases, ≤ 5×ULN); serum total bilirubin (TBIL) ≤ 1.5×ULN (for subjects with Gilbert syndrome, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance ≥ 60mL/min;
• Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;
• Urinalysis shows urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification should be < 1g;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
• 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.

Критерии исключения

• Patients participating in other clinical trials at the same time, unless they are in an observational, non-interventional clinical study or the follow-up period of an interventional study;
• Subjects with rare histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc.;
• Subjects who have had other malignant tumors within 3 years before enrollment, except for cervical cancer. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, breast carcinoma in situ, etc.;
• A history of allergic reactions, hypersensitivity reactions, or intolerance to antibody-based drugs; a history of significant allergies to drugs, food, or other substances;
• Those with no measurable lesions or unevaluable lesions;
• Having received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first dose;
• Having received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose;
• Having active autoimmune diseases requiring systemic treatment within the past two years;
• Having a history of non-infectious pneumonia requiring systemic glucocorticoid treatment, a history of pneumonia, or a current history of interstitial lung disease;
• Having a history of immunodeficiency; positive HIV antibody test; currently receiving long-term systemic corticosteroids or other immunosuppressants;
• A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
• Subjects with evidence or history of thrombosis or obvious bleeding tendency within 2 months before the first administration of the study drug (bleeding > 30 mL within 2 months, with hematemesis, melena, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks);
• Having uncontrolled comorbidities, including but not limited to: active HBV or HCV infection; known HIV infection or AIDS history; active syphilis; active tuberculosis; active infection; uncontrolled hypertension, symptomatic cardiac insufficiency; active bleeding;
• Pregnant or lactating women;
• Active or uncontrolled severe infections (≥ CTCAE5.0 grade 2 infections), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia, and unexplained fever > 38.5℃ before the first dose;
• A clear history of mental disorders (including epilepsy or dementia); or other conditions that the investigator deems inappropriate for participation in the study;
• Patients who the investigator judges are unlikely to comply with the study procedures, restrictions, and requirements must not participate in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07466901 · GUARD-CC-ADJ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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