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The treatment of Camrelizumab and Apatinib on recurrent ovarian epithelial cancer -A single arm, single center, prospective phase II clinical study

The treatment of Camrelizumab and Apatinib on recurrent ovarian epithelial cancer -A single arm, single center, prospective phase II clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070839
Enrollment
Unknown
Registered
2023-04-24
Start date
2021-04-06
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

ovarian epithelial cancer

Interventions

Experimental group:Camrelizumab: 200mg iv d1 q2w
Apatinib: 250mg qd
Treatment until disease progression, intolerable toxicity or death

Sponsors

Tianjin cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Sign a written informed consent form before joining the group; 2) Age>=18 years old and= 10mm or a short diameter of >= 15mm for enlarged lymph nodes); 6) The functional level of the main organs must meet the following requirements: -Blood routine: ANC >= 1.5 × 10^9/L; PLT>=90 × 10^9/L; Hb>=90 g/L; -Blood biochemistry: TBIL = 50%; 8) 12 lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for males= 50 ml/min; 10) No blood transfusion within 2 weeks prior to screening; 11) For female subjects who have not undergone menopause or surgical sterilization, during the treatment period and during the study treatment, agree to abstain or use effective contraceptive methods for at least 7 months after the second administration; 12)Volunteer to join this study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions cannot be included in this study: 1) Previously used PD-1 inhibitors or PD-L1 inhibitors; 2) Simultaneously receiving anti-tumor therapy in other clinical trials; 3) Inoculate live attenuated vaccines within 4 weeks before the first administration or during the study period; 4) Has undergone major surgical procedures unrelated to epithelial ovarian cancer within 4 weeks prior to the trial, or if the subject is still Not fully recovered from such surgical procedures; 5) Severe infection (such as requiring intravenous drip of antibiotics, antifungal agents, or antibiotics) within 4 weeks before the first medication use Viral drugs), or unexplained fever>38.5 ° C during screening/before first administration; 6) The first administration time is within the washout period of the anti vascular drug (defined as 5 and a half months of the drug in this protocol) Aging period, among which: ? If it is less than 30 days, it will be calculated based on 30 days, that is, the distance between the last medication time and enrollment The medication time should be at least 30 days apart, and if it exceeds 30 days, it should be calculated based on the actual time; 7) Individuals with a known history of allergies to the drug components of this protocol; 8) Patients at risk of severe bleeding, including but not limited to severe bleeding (>30 ml within 3 months), hemoptysis (>5 ml within 4 weeks), and thromboembolic events (including stroke events) within 12 months And/or transient ischemic attack); 9) Individuals with hypertension who have been treated with antihypertensive drugs for 3 months but are still unable to reduce to normal range (systolic blood pressure <= 140 mmHg/diastolic blood pressure <= 90 mmHg); 10) There is objective evidence indicating past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation lung disease Inflammation, drug-related pneumonia, severe damage to lung function, etc; 11) Have a history of immune deficiency, including HIV testing positive, or other acquired or congenital immunity Defective diseases or a history of organ transplantation. 12) Have suffered from any heart disease, including: (1) angina pectoris; (2) Possible clinical conditions that require medication treatment Meaning of arrhythmia; (3) Myocardial infarction; (4) Heart failure; (5) Any researcher Other heart diseases deemed unsuitable for participation in this trial. 13) Pregnant and lactating female patients with fertility and positive baseline pregnancy test results Female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the entire trial period. 14) According to the judgment of the investigator, there is a serious danger to the safety of the patient safety, or influence on the completion of the study Disease (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.); 15) Unable to swallow, chronic diarrhea, and intestinal obstruction, there are various factors that affect drug administration and absorption. 16) Any other circumstances in which the researcher believes that the subject is not suitable to participate in this study

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
progression-free survival;disease control rate;Time until the next treatment;overall survival;

Countries

China

Contacts

Public ContactWenxin Liu

Tianjin cancer hospital

wenxin1973@163.com+86 186 2222 1101

Outcome results

None listed

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