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A phase II single-arm study for Sintilimab combined with Albumin-bound paclitaxel in the treatment of platinum-resistant recurrent epithelial ovarian cancer/fallopian tube cancer/primary peritoneal adenocarcinoma

A phase II single-arm study for Sintilimab combined with Albumin-bound paclitaxel in the treatment of platinum-resistant recurrent epithelial ovarian cancer/fallopian tube cancer/primary peritoneal adenocarcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031890
Enrollment
Unknown
Registered
2020-04-13
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer/fallopian tube cancer/primary peritoneal adenocarcinoma

Interventions

Case series:chemotherapy and immunotherapy

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged >=18 years; 2. histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.Types: non-specific adenocarcinoma (NOS), clear cell carcinoma, endometrioid adenocarcinoma, malignant brenner's tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma and undifferentiated carcinoma; 3. at least one measurable tumor lesion (according to RECIST1.1); 4. ECOG score 0-1; 5. the subject must have appropriate organ functions, and the results of the following laboratory tests were met before enrollment: 1) bone marrow reserve was basically normal: ANC>=1.5x10^9/L, HB>=90 g/L, PLT>=100x10^9/L; 2) liver function was basically normal: TBIL=60mL/min, calculated according to the cockroft-gault formula: male GFR=(140-age)*BW/(Scr*72), female GFR= male *0.85; 4) basically normal coagulation function: INR=12 weeks; 8. at least 4 weeks from the latest chemotherapy, and at least 4 half-life elution is required if anti-tumor biological products have been received; 9. toxic and side effects caused by previous treatment should be restored to <=level 1 (CTCAE5.0); 10. subject shall give informed consent to this study before the test and voluntarily sign a written informed consent; 11. the subject can communicate well with the researcher and complete the study according to the study regulations.

Exclusion criteria

Exclusion criteria: 1. age > 75 years old; 2. ECOG score >=2 points; 3. ovarian tumors with low malignant potential, such as borderline tumors; 4. the patient has other invasive malignant tumors (except non-melanoma skin cancer) or previous malignant tumor treatment is contraindicated in the current treatment regimen; 5. severe infections require intravenous antibiotics or hospitalization; 6. CNS disease unrelated to tumor, symptomatic brain metastasis; 7. complete intestinal obstruction; 8. sensitivity to Albumin-bound paclitaxel or sintilimab; 9. the patient has previously received immunotherapy, such as pd-1 antibody, pd-l1 antibody, CTLA4 antibody, etc. 10. used immunosuppressive drugs within 4 weeks, not including the nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisone or other equivalent dose glucocorticoids), allowing for treatment of diseases such as asthma, chronic obstructive pulmonary disease, breathing difficulties for the temporary use of glucocorticoid.

Design outcomes

Primary

MeasureTime frame
Tumor markers test;Target lesion;

Countries

China

Contacts

Public ContactZheng Hong

Beijing Cancer Hospital

zheng_111_hong@126.com+86 13641356816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026