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A single-arm, prospective clinical study of camrelizumab combined with cryotherapy in patients with resectable solid tumors

A single-arm, prospective clinical study of camrelizumab combined with cryotherapy in patients with resectable solid tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040124
Enrollment
Unknown
Registered
2020-11-22
Start date
2020-11-23
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Resectable solid tumor

Interventions

1:camrelizumab for injection
1:Freeze

Sponsors

Suzhou Wuzhong People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Pathologically diagnosed as a cancer patient, and the lesion is resectable or potentially resectable; 3. The patient signed an informed consent form and voluntarily joined the study; 4. Physical fitness score ECOG 0-1 points; 5. Expected survival period >=3 months; 6. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency; 7. Neutrophils>=1.5x10^9/L; hemoglobin>=9g/dL; platelets>=100x10^9/L; total bilirubin<=1.5 ULN; AST (SGOT) and ALT (SGPT)<=2.5 ULN; creatinine <=1.5 ULN; 8. The investigator determined that the patient can be treated with carrelizumab; 9. The researcher determines that the patient can receive cryotherapy technology.

Exclusion criteria

Exclusion criteria: 1. Suffer from any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormonal After replacement therapy is effective, it can be included), etc.), and use immunosuppressive agents within 28 days; those with medical history, except for the use of hormones to deal with the toxicity of radiotherapy and chemotherapy; 2. There is an abnormal thyroid function in the past, and under the condition of drug treatment, the thyroid function still cannot be maintained within the normal range; 3. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 4. Have received or are currently receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 5. Known to be allergic to macromolecular protein preparations, or to any carrelizumab (SHR-1210) and its ingredients; 6. Suffer from uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure above NYHA II; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 7. Suffer from congenital or acquired immune function defects (such as HIV infection), active hepatitis B (HBV-DNA >=10^4 copies/ml) or hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the detection limit of the analysis method) or active tuberculosis; 8. Active infection or fever of unknown cause occurred within 2 weeks before randomization> 38.5 degree C (according to the judgment of the investigator, the subject can be included in the group for fever caused by tumor); 9. Males or females with fertility are unwilling to take contraceptive measures in the trial, and female patients are pregnant or breastfeeding; 10. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) that require combined treatment; Court or social factors may affect the safety of subjects or the collection of experimental data; 11. The investigator judges other situations that are not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactLi Zhong

Suzhou Wuzhong People's Hospital

lizhong5179@me.com+86 13952408101

Outcome results

None listed

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