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A real-world study on the safety and efficacy of Camrelizumab for advanced lung cancer

A real-world study on the safety and efficacy of Camrelizumab for advanced lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048607
Enrollment
Unknown
Registered
2021-07-11
Start date
2021-07-15
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

lung cancer

Interventions

Observation group:Camrelizumab

Sponsors

Affiliated Cancer Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with advanced lung cancer diagnosed by pathology or clinical diagnosis; 2. Have measurable tumor lesions (spiral CT scan >=10mm, meeting RECIST 1.1 criteria); 3. Expected survival > 3 months; 4. Aged 18 to 70 years old, male or female; 5. ECOG PS 0-2 points; 6. The functions of vital organs meet the following requirements: (1) Absolute neutrophil count >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=9g/dL; (2) Bilirubin 35g/ml, prothrombin time prolongation 60 mL/min; 7. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women of childbearing age and men (having sex with women of childbearing age) must agree to use effective without interruption during treatment and for 6 months after the last therapeutic dose contraceptive measures; 8. The physician believes that it may benefit from camrelizumab treatment and accepts the treatment voluntarily; 9. The patients voluntarily joined the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffered from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ. 2. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before the medication should be excluded even if they have been treated.Patients with a history of active pulmonary tuberculosis infection more than 1 year ago are also excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment. 3. Observed patients with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected. 4. Patients whose adverse reactions of the last treatment plan did not return to Grade 1 or normal. 5. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months. 6. Patients receiving hematopoietic stem cell or organ transplantation. 7. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of camrelizumab. 8. Pregnant or lactating women. 9. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up. 10. There is a history of psychotropic drug abuse, alcohol or drug abuse. 11. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive. 12. The researcher thinks it is inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Immune inspection index;

Secondary

MeasureTime frame
objective response rate;disease control rate;progression-free survival;overall survival;

Countries

China

Contacts

Public ContactWang Xiaohong

The Affiliated Cancer Hospital of Harbin Medical University

851539995@qq.com+86 13303602615

Outcome results

None listed

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