advanced ovarian cancer
Conditions
Interventions
Group B:Control Arm: Guideline-Recommended Standard Chemotherapy (Paclitaxel + Carboplatin)
Group A:Experimental Arm: Cadonilimab + Famitinib + Carboplatin
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before any procedure can be carried out, an informed consent form must be signed and the form must be filed at the research center. 2. Female patients whose age is 18 or above; 3. Biopsies were obtained through open surgery, laparoscopic surgery, or fine-needle aspiration. The pathological examination confirmed that the lesions were high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (referred to as ovarian cancer); 4. FIGO stage III-IV; 5. Blood and tissue samples of the patients before, during and after the treatment can be obtained, and the subjects have agreed to hand over the blood and tissue samples to the central laboratory for the expansion research purposes of this trial, including but not limited to: i. possible genetic-related research. ii. possible tumor marker-related research; 6. There is at least one lesion that can be measured by CT/MRI; 7. Believed not suitable for the initial tumor reduction surgery (PDS): (1) Meeting the high-risk perioperative complication criteria of the Mayo standard; (2) If imaging cannot determine whether the tumor is resectable, laparoscopic examination is the preferred option. If the Fagotti score under laparoscopy is >= 8 points, and there is extensive small intestine involvement or mesenteric contracture, and the following conditions are met: 1) Albumin = 80 years; 3) Age 75-79 years, and one of the following conditions exists: PS > 1 (ASA 3-4); or stage IV (multiple liver metastases or lung metastases); or complex surgical procedures (exceeding uterus + bilateral ovaries + greater omentum resection); within the past 6 months: VTE; or myocardial infarction; or vascular stent placement; or open surgery. Fagotti score (2 points per item) Large/granular abdominal peritoneal implantation lesions; Greater omentum cake involving the greater curvature of the stomach; Extensive peritoneal infiltrative lesions and/or most of the diaphragmatic surface involved; Mesenteric root involvement; Small intestine/large intestine resection and/or extensive implantation of lesions on the intestine;Tumor infiltration of the gastric wall; Surface lesions on the liver > 2 cm. 8. Expected survival period > 12 weeks; 9. The patient's ECOG score is 0-2; 10. The patient should have good organ functions and meet the following laboratory criteria: (1) Within the last 14 days, without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) should be >= 1.5 × 10^9/L. (2) Within the last 14 days, without blood transfusion, the platelet count should be >= 100 × 10^9/L. (3) Within the last 14 days, without blood transfusion or use of erythropoietin, the hemoglobin should be > 9 g/dL; (4) Total bilirubin = 50 ml/min; (6) Good coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN. 11. For women with reproductive potential, the pregnancy test in blood or urine must be negative within one week before enrollment. After enrollment, effective contraceptive measures must be taken, such as using physical barrier con
Exclusion criteria
Exclusion criteria: 1. Concurrently with this research, other experimental drugs were used and other clinical drug trials were participated in; 2. Concurrent with this research, other neoadjuvant treatment methods for tumors were employed, including but not limited to: chemotherapy, radiotherapy, immunotherapy, microbiological treatment, traditional Chinese medicine treatment, and other experimental therapies; 3. Individuals known to be allergic to famitinib/cadonil or to the active or inactive components of drugs with similar chemical structures to them; 4. Unable to take oral medications, and having any gastrointestinal disorders that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, digestive tract obstruction, or malabsorption; 5. Has received any cancer treatment related to ovarian cancer; 6. Has previously received known or potential TKI inhibitors/ICB immunotherapy; 7. Symptomatic or uncontrolled brain metastases that require concurrent treatment, including but not limited to surgery, radiotherapy and/or corticosteroids, or clinical manifestations of spinal cord compression; 8. Those who had undergone major surgery within the previous 3 weeks, or who were still not recovered after the surgery; 9. The subjects had other malignant diseases within the past 3 years, except for skin squamous cell carcinoma, basaloid carcinoma, intraductal carcinoma of the breast, or cervical carcinoma in situ that had been effectively treated. 10. The patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 11. Subjects with severe and uncontrolled diseases or those whose general condition, as determined by the researchers, is not suitable for participation in the study, including but not limited to: active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C; severe cardiovascular diseases, uncontrolled ventricular arrhythmias, myocardial infarction within the last 3 months; uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the subject's ability to sign the informed consent; uncontrolled hypertension; immunodeficiency (except for splenectomy) or other diseases that the researchers consider may expose the subject to high-risk toxicities; 12. Any past medical history or current clinical evidence indicates the possibility of confusion in the research results, interference with the patient's compliance with the trial protocol throughout the entire treatment period, or deviation from the patient's best interests. 13. The patient had received platelet or red blood cell transfusions within 3 days prior to starting the treatment with the investigational drug; 14. Patients who are pregnant or breastfeeding, or who plan to become pregnant during the course of the study treatment. 15. There is unresolved previous treatment toxicity in the clinical setting (>= grade 2, excluding hair loss, neuralgia, lymphocyte reduction, and skin depigmentation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR);Objective response rate;Progression-free survival and overall survival;quality of life; | — |
Countries
China
Contacts
Public ContactXipeng Wang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed