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Real World Study of Camrelizumab combined with Apatinib and brachytherapy in the treatment of metastatic / persistent / recurrent cervical cancer

Real World Study of Camrelizumab combined with Apatinib and brachytherapy in the treatment of metastatic / persistent / recurrent cervical cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038689
Enrollment
Unknown
Registered
2020-09-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-12-14

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:Camrelizumab, apatinib, brachytherapy

Sponsors

Jiang Ping
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with metastatic / persistent / recurrent cervical cancer who failed or could not tolerate chemotherapy after previous chemotherapy; 2. By pathological and imaging diagnosis, the maximum diameter of the mass does not exceed the maximum diameter of particle therapy (5-7 cm); 3. Aged 18 to 70 years; 4. ECOG score 0-1, can tolerate puncture; 5. According to the RECIST1.1,the lesions can be evaluated clinically, and the target lesions are not suitable for surgical treatment; 6. The estimated survival time is more than 3 months. 7. The main organ function indexes meet the standard of routine immunotherapy and targeted therapy; 8. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study and the results are negative, and are willing to use a medically approved and effective contraceptive method during the study period and within 3 months after the last study drug is given (e.g. intrauterine devices, birth control pills or condoms); 9. The subjects should sign informed consent to understand the purpose of the study and the operation required by the study and participate in the study voluntarily.

Exclusion criteria

Exclusion criteria: 1. Have received an equal immunotherapy; or have participated in clinical trials of other anti-tumor drugs within 4 weeks of first administration; or have received live attenuated vaccines within 4 weeks of first administration or during study. 2. Subjects had other malignancies in the past three years. 3. Subjects used immunosuppressive drugs within 14 days prior to the first use of carrelizumab, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e. no more than 10 days mg/ prednisolone or other corticosteroids the same physiological dose)?. 4. Patients with symptoms, spread to the viscera and risk of life-threatening complications in the short term (including patients with uncontrolled mass exudates [chest, pericardium, abdominal cavity], pulmonary lymphangitis and more than 30% liver involvement). 5. Any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma fully relieved without any intervention in adults; subjects with bronchodilators for medical intervention of asthma can not be included)?. 6. Hypertension beyond drug control (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg). 7. Patients with myocardial ischemia or myocardial infarction above grade II, arrhythmia with poor control (including men =450 ms, women =470 ms). Under NYHA criteria, grade III ~ IV cardiac insufficiency, or echocardiography indicated that left ventricular ejection fraction was less than 50%; myocardial infarction occurred within 6 months prior to group entry, heart failure of grade II or above, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or abnormal active conduction system. 8. Abnormal coagulation function (INR>1.5 or prothrombin time> ULN 4 seconds or APTT> 1.5 ULN), bleeding tendency or undergoing thrombolytic or anticoagulant therapy. 9. Subjects with significant cough blood, or hematemesis (2.5 ml) or more within 2 months prior to the study; or 3 months before entering the study had significant clinical significance of bleeding symptoms or have a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline stool occult blood ++ and above, or suffering from vasculitis; or thrombotic events occurring within 6 months prior to participating in the study, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism. 10. Severe infections (e.g. requiring intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks prior to initial administration, or fever > 38.5? of unknown cause prior to initial administration. 11. Subjects with a history of substance abuse and no withdrawal or mental disorders. 12. Subjects underwent major surgery within 4 weeks before the first medication. Or open wounds or fractures. 13. Subjects had significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, or had sinus or perforation of cavity organs within 6 months. 14. Urine routine indicates urinary protein = ++, or 24 hours urine protein =1.0 g 15.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progress Free Survival;Six Month Disease Control Rate;One Year Overall Survival;Safety;

Countries

China

Contacts

Public ContactJiang Ping

Peking University Third Hospital;

531240769@qq.com+86 13439796018

Outcome results

None listed

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