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Exploratory clinical study of Camrelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer

Exploratory clinical study of Camrelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068704
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-02-27
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Locally advanced cervical cancer

Interventions

Test group:Camrelizumab in combination with concurrent chemoradiotherapy

Sponsors

Jiamusi Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Cervical cancer diagnosed histologically or cytologically (2018 FIGO stage IIB-IVA initial treatment) with measurable tumor lesions (spiral CT or MR Scan =10mm, meeting RECIST 1.1 criteria); 2. No previous immunotherapy; 3. Age: 18 ~ 70 years old; Female; 4.ECOG score: 0-2; 5. Expected survival > 3 months; 6. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors during screening) : a) Neutrophil absolute count =1.5×109/L, platelet =100×109/L, hemoglobin =90g/dL; b) Bilirubin =1.5 ULN (patients with retrograde drainage may include); ALT and AST =5 ULN, albumin > 35g/ml, prothrombin time 60 mL/min; Patients volunteered to join the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or those who are fertile but refuse to take contraceptive measures; 2. A history of other malignancies in the past 5 years; 3. Allergic to any tested drug and its excipients, with a history of severe allergy or contraindications to the tested drug; 4. Patients with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or with severe intellectual or cognitive dysfunction; 5. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of lung function; 6. Subjects with active, known, or suspected autoimmune diseases requiring hormone replacement therapy for hypothyroidism, skin conditions requiring no systemic therapy (such as vitiligo, psoriasis, or alopecia) are eligible; 7. Congestive heart failure, uncontrolled arrhythmia, myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months; 8. Severe active infections requiring intravenous antibiotic therapy occurred during the enrollment period; 9. Received or will receive live vaccine within 30 days prior to camrelizumab administration; 10. Known history of HIV infection; 11. Patients who cannot follow the trial protocol or cooperate with follow-up; 12.Researchers consider it inappropriate to participate in this study.

Design outcomes

Secondary

MeasureTime frame
Disease control rate, DCR;Progression-free survival, PFS;Overall survival OS;safety;

Primary

MeasureTime frame
Objective remission rate, ORR;

Countries

China

Contacts

Public ContactXueliang Zhang

Jiamusi Cancer Hospital

378770644@qq.com18145450777

Outcome results

None listed

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