Recurrent and metastatic cervical cancer
Conditions
Interventions
Experimental Group:Camrelizumab + Nimotuzumab + CCRT
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. ECOG score 0-1; 3. Inclusion population (FIGO 2018 staging): 3.1 Patients with recurrence/metastasis after radical surgery and suitable for local treatment; 3.2 Patients with field recurrence/metastasis after synchronous chemoradiotherapy and suitable for local treatment 3.3 Stage IVB patients who have not received systemic treatment and are suitable for local treatment. 4. Confirmed as cervical squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma by pathological histology 5. Estimated survival period >=3 months; 6. According to the RECIST 1.1 evaluation criteria, at least one measurable lesion must be present; 7. The functional level of major 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%; 9. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 450 ms for males and < 500 ms for females 470 ms; 10. No blood transfusion and erythropoietin were used within 2 weeks before screening; 11. Women with potential fertility had negative blood ß-HCG or urine pregnancy test within 72 hours before administration (postmenopausal women with amenorrhoea for at least 12 months are considered infertile, and women who are known to have undergone tubal ligation are not required to undergo pregnancy test); 12. Female subjects who are not menopausal or have not undergone surgical sterilization agree to abstain from sex or use effective contraceptive methods during treatment and for at least 7 months after the last dose of study treatment; 13. Volunteer to join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received nimotuzumab or other anti-EGFR treatment, received carrelizumab, other PD-1/PD-L1 or another stimulatory or co-inhibitory T cell receptor (such as CTLA-4) drug treatment; 2. Subjects are known to have been allergic to large molecule protein preparations, or to any nimotuzumab or carrelizumab component; 3. 5 days before the first dose Diagnosed with other malignancies within the year, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, radically resected carcinoma in situ and/or papillary thyroid carcinoma; 4. Other targeted therapies, anti-VEGF therapy or other anti-tumor therapies not included in this trial protocol; 5. Systemic chemotherapy for cervical cancer (except for postoperative adjuvant chemotherapy and concurrent chemoradiotherapy for local advanced cervical cancer, which must be completed at least 2 weeks before the screening period, and participants must have recovered from all radiotherapy-related toxicities and no radiation pneumonia); 6. Women of childbearing age who are pregnant, breastfeeding, planning to become pregnant or not taking reliable birth control measures, and are unwilling to take birth control measures during the study and within 7 months after the last medication; 7. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or fistula risk; 8. Major surgical procedures unrelated to cervical cancer within 4 weeks before enrollment, or subjects have not fully recovered from such surgical procedures; 9. History of immunodeficiency, including HIV Test positive, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 10. Receiving chronic systemic steroid therapy (doses exceeding 10 mg of prednisone equivalents per day) or any other form of immunosuppressive therapy within 7 days before randomization; 11. Suffering from active autoimmune diseases and requiring systemic treatment (using disease-modifying agents, corticosteroids, or immunosuppressive drugs) in the past two years. Replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment and is allowed; 12. Active infection confirmed by hepatitis B five-item test, or hepatitis B virus infection (HBV DNA >= 1000 IU/ml); hepatitis C virus infection (HCVRNA positive); 13. Known history of active pulmonary tuberculosis; 14. Patients with meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases or stable symptoms for =2 weeks after treatment of brain metastases can participate in this study as long as they meet all of the following criteria: measurable lesions outside the central nervous system; no meningeal, midbrain, pons, cerebellum, medulla oblongata, or spinal cord metastases; no history of intracranial hemorrhage; hormonal treatment was stopped 14 days before the first dose of study drug; brain metastases are stable in imaging (need to be judged by two imaging examinations: 1) The first imaging examination is obtained after the completion of treatment of brain metastases; 2) The second imaging examination must be obtained during the screening period (i.e. within 28 days before random selection) and within >4 weeks after the last post-treatment imaging examination. ); 15. Patients with active brain metastases: Brain imagi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressicn free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Disease Control Rate,DCR;Duration of Response,DoR;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactZhongjie Chen
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed