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Efficacy and safety of SHR-1210, Apatinib and nab-paclitaxel in the second-line treatment of recurrent / metastatic cervical cancer: a single arm, exploratory study

Efficacy and safety of SHR-1210 combined with Apatinib and Paclitaxel(albumin bound) in the second-line treatment of recurrent / metastatic cervical cancer: a single arm, exploratory study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052395
Enrollment
Unknown
Registered
2021-10-24
Start date
2019-09-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

cervical cancer

Interventions

Case series:SHR-1210 combined with Apatinib and Paclitaxel(albumin bound)

Sponsors

Wuhan union hospital, Huazhong University of science and technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects who meet all the following criteria can be selected for this study: 1. Aged 18 ~ 70 years old, female; 2. For cervical cancer diagnosed by histology or cytology, the first-line standard treatment recommended by NCCN guidelines has been carried out, and the condition is progressing; 3. According to RECIST 1.1 standard, the patient has at least one target lesion with measurable diameter; 4. ECoG PS 0-1 point; 5. The functions of important organs shall meet the following requirements: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L; (2) Platelet >=100x10^9/L; (3) Hemoglobin >=90g/L; (4) Bilirubin =50ml / min; (6) Thyroid function is normal. 6. Estimated survival time >=3 months; 7. Female subjects with fertility shall conduct urine or serum pregnancy test within 72 hours before receiving the first study drug and prove to be negative, and are willing to use effective contraceptive methods from the test period to 3 months after the last administration of shr-1210; 8. The patients voluntarily joined the study and signed the informed consent form (ICF), with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. The patient has any active autoimmune disease or has a history of autoimmune disease; 2. The patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10mg / day, prednisone or other effective hormones); 3. Severe allergic reaction to other monoclonal antibodies; 4. Suffering from hypertension and can not be well controlled by antihypertensive drugs (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 5. There are clinical symptoms or diseases of heart that are not well controlled; 6. Abnormal coagulation function (INR > 2.0, Pt > 16S), bleeding tendency or undergoing thrombolytic or anticoagulant therapy, allowing the preventive use of low-dose aspirin and low molecular weight heparin; 7. Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before enrollment; 8. Routine urine examination showed that urinary protein >=+ + and it was confirmed that 24-hour urinary protein > 1.0 g; 9. The patient has active infection, unexplained fever >=38.5 degree C within 7 days before medication, or baseline leukocyte count > 15x10^9/L; 10. The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1 / PD-L1, or has previously received apatinib therapy or albumin bound paclitaxel therapy; Other patients considered unsuitable by the attending physician.

Design outcomes

Primary

MeasureTime frame
objective remission rate (ORR);

Countries

China

Contacts

Public ContactG.L.Li

Wuhan Union Hospital, Huazhong University of Science and Technology

lgl6714@163.com+86 13307187507

Outcome results

None listed

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