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An exploratory clinical study of camrelizumab combined with chemotherapy in adjuvant treatment of stage IIA-IIIA non-small cell lung cancer

An exploratory clinical study of camrelizumab combined with chemotherapy in adjuvant treatment of stage IIA-IIIA non-small cell lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053236
Enrollment
Unknown
Registered
2021-11-17
Start date
2021-11-22
Completion date
Unknown
Last updated
2023-01-23

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

Conditions

non-small cell lung cancer (NSCLC)

Interventions

Experimental group:camrelizumab combined with platinum-containing chemotherapy

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 stage IIA-IIIA non-small cell lung that have achieved R0 resection and postoperative pathological confirmation; 2. Have not received neoadjuvant therapy before; 3. Have not received radiotherapy before; 4. Expected survival period > 3 months; 5. Aged >=18 years, no gender limit; 6. ECOG PS: 0-1 points; 7. The functions of vital organs meet the following requirements: (1) Absolute neutrophil count >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 9g/dL; (2) Bilirubin 60 mL/min; 8. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, women of childbearing age and men (who have sex with women of childbearing age) must agree to use effective contraception without interruption during treatment and for 6 months after the last therapeutic dose; 9. The patients voluntarily joined the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. EGFR gene mutation positive or ALK positive; 2. Suffering from other malignant tumors in the past or at the same time, except for the cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before dosing, even if they have been treated, should be excluded. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago are also excluded, unless it is proved that they have received standard anti-tuberculosis treatment before; 4. Those with uncontrolled or symptomatic brain metastases or with a history of uncontrollable mental illness or with severe intellectual or cognitive dysfunction; 5. Suffering from active, known or suspected autoimmune disease, patients with hypothyroidism who only receive hormone replacement therapy, and skin diseases that do not require systemic therapy (such as vitiligo, psoriasis, or alopecia) can be enrolled; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack within 6 months; 7. Patients who cannot comply with the trial protocol or who cannot cooperate with follow-up; 8. Have a history of psychotropic substance abuse, alcoholism or drug use; 9. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 10. The researchers believe that it is not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Disease-free survival (DFS) rate;

Secondary

MeasureTime frame
Disease free survival;Overall survival;

Countries

China

Contacts

Public ContactXu Shidong

Affiliated Cancer Hospital of Harbin Medical University

xusd163@163.com+86 13903611962

Outcome results

None listed

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