Ovarian Cancer
Conditions
Interventions
Experiment group:Sintilimab combined with weekly paclitaxel and anlotinib
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent obtained prior to any trial-related procedures; 2. Female patients aged >=18 years; 3. ECOG performance status of 0-1; 4. Histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal adenocarcinoma; Disease recurrence/progression during or within 6 months after completing platinum-based chemotherapy (>=4 cycles). Note: Recurrence/progression requires: Objective radiological evidence or clinical progression (e.g., new ascites/pleural effusion with positive cytology); 5. Life expectancy >=12 weeks; 6. >=1 measurable lesion per RECIST v1.1: Non-nodal lesions: Long axis >=10 mm on spiral CT; Lymph nodes: Short axis >=15 mm; Previously irradiated lesions may qualify if documented progression post-treatment; 7. Adequate organ and bone marrow function, as evidenced by the following laboratory values (no blood products, growth factors, albumin, or corrective medications within 14 days prior to testing): (1) Hematologic: Absolute neutrophil count (ANC) >=1.5×10^9/L;Platelet count (PLT) >=90×10^9/L;Hemoglobin (HGB) >=9.0 g/dL; (2) Hepatic: Total bilirubin (TBIL) =28 g/L;Alkaline phosphatase (ALP) =40 mL/min (*Cockcroft-Gault formula*); Urinalysis: Protein =2+, 24-hour urine protein must be =1 year) or Surgically sterile (hysterectomy/oophorectomy); 9. Contraception: All participants at risk of pregnancy must use highly effective contraception (failure rate <1%/year) during treatment and for 120 days post-last dose; 10. All prior anticancer therapy-related toxicities must resolve to Grade 0-1 (per NCI CTCAE v5.0) or eligibility-specified levels. Exceptions: Non-safety risks (e.g., alopecia) per investigator judgment.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of malignancies other than recurrent ovarian/fallopian tube/primary peritoneal adenocarcinoma within 5 years before the first dose. Exceptions: Cured basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ; 2. Current participation in other interventional trials or use of investigational drugs/devices within 4 weeks prior to the first dose; 3. Previous treatment with anti-PD-1/PD-L1/PD-L2 agents or other T-cell-targeted therapies (e.g., CTLA-4, OX-40, CD137 inhibitors); 4. Anlotinib administrated within 2 months before the first dose; 5. Radiation therapy within 4 weeks prior to the first dose. Exceptions: Patients irradiated >4 weeks earlier may enroll if: No residual radiation-related toxicities; No corticosteroid requirement; No radiation-induced hepatitis/enteritis; 6. Systemic use of antitumor traditional Chinese medicine or immunomodulators (e.g., thymosin, interferon, interleukin) within 2 weeks before the first dose. Exception: Local use for pleural effusion control; 7. History of autoimmune disease requiring systemic treatment (e.g., immunosuppressants, corticosteroids) within 2 years. Allowed: Hormone replacement (thyroxine, insulin) or physiologic corticosteroid doses (10 mg/day prednisone equivalent) or immunosuppressants within 4 weeks before the first dose. Allowed: Topical/noninhalational corticosteroids; 9. Allogeneic organ (except corneal) or hematopoietic stem cell transplantation; 10. Known allergy to sintilimab, paclitaxel, anlotinib, or their excipients; 11. Factors impairing oral intake (e.g., dysphagia, chronic diarrhea, intestinal obstruction, post-gastrointestinal resection); 12. HIV-1/2 antibody positivity; 13. Untreated active HBV (HBsAg+ with HBV-DNA > upper limit of normal [ULN]). Exceptions: (1) HBV-DNA =Grade 2 AV block, ventricular arrhythmias, atrial fibrillation); (2) Unstable angina, chronic heart failure (NYHA Class >=II); (3) Any arterial thrombotic, embolic, or ischemic events within 6 months prior to treatment initiation, including but not limited to: myocardial infarction unstable angina cerebrovascular accident (stroke), transient ischemic attack (TIA); (4) Major surgery (thoracic/abdominal/cranial) within 4 weeks or unhealed wounds/fractures. Minor procedures (e.g., biopsy) within 7 days (allowed: IV catheter placement); (5) Poorly controlled hypertension (SBP >150 mmHg or DBP >90 mmHg); (6) Active tuberculosis; (7) Uncontrolled infections requiring systemic therapy; (8) Clinically significant diverticulitis, abdominal abscess, or bowel obstruction; (9) Decompensated liver disease (e.g., cirrhosis, active hepatitis); (10) Poorly controlled diabetes (fasting glucose >10 mmol/L); (11) Proteinuria >=++ with 24-hour urine protein >1.0 g; (12) Psychiatric disorders affecting compliance; 18. Participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Remission Rate (ORR);Overall Survival(OS);Disease control rate, DCR;Continuous remission rate;Safety and tolerability (incidence of adverse events (AE) and serious adverse events (SAE), incidence of treatment termination caused by AE/SAE); | — |
Countries
China
Contacts
Public ContactLiu Ziling
Cancer Center, the First Hospital of Jilin University
Outcome results
None listed