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The clinical study of carrelizumab for maintenance treatment of stage III unresectable NSCLC after concurrent radiotherapy and chemotherapy

The clinical study of carrelizumab for maintenance treatment of stage III unresectable NSCLC after concurrent radiotherapy and chemotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054107
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-09
Completion date
Unknown
Last updated
2022-11-07

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

Interventions

experimental group:Carrelizumab 200mg q3w

Sponsors

Anhui Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18~75 years old, male or female; 2. Patients with unresectable and unresectable stage IIIA-IIIC non-small cell lung cancer confirmed by histopathology or cytology; 3. The disease has not progressed after concurrent chemoradiotherapy with platinum-containing regimen (at least 2 cycles); 4. ECOG PS score 0-1 points; 5. Expected survival period >= 6 months; 6. The main organ functions are normal, and there are no patients with severe blood, lung, liver, kidney, bone marrow and other functional abnormalities. Laboratory inspections meet the following requirements: (1) Hemoglobin (Hb) >= 90 g/L; (2) White blood cells (WBC) >=3.0x10^9/L; neutrophil count (NEUT) >=1.5x10^9/L; (3) Platelet (PLT)>=100x10^9/L (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <= 2.5 times the upper limit of normal (ULN); renal function (serum creatinine sCr) level <= 1.5 times the upper limit of normal (ULN); (5) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); (6) Urine protein and urine occult blood <2+; fecal occult blood <2+. 7. History of pneumonia or interstitial pneumonia without hormone control; 8. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; 9. The investigator believes that the treatment can be beneficial.

Exclusion criteria

Exclusion criteria: 1. Those who have proved allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 3. Suffering from any active autoimmune disease or history of autoimmune disease; 4. Suffering from congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/mL), hepatitis C (positive hepatitis C antibody, and high HCV-RNA) (the lower limit of detection of the analytical method) or co-infection of hepatitis B and C; or a history of organ transplantation; 5. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure of NYHA grade 2 or above; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; 6. Pregnant or lactating women; 7. Patients who are judged by the researchers to be unsuitable for inclusion in this study; 8. Those with internal medical system diseases and psychiatric diseases who are not suitable for chemotherapy; 9. Those with acute infection requiring antibiotic treatment; 10. Patients who have participated in clinical trials of other drugs within four weeks.

Design outcomes

Primary

MeasureTime frame
2-year survival rate;

Countries

China

Contacts

Public ContactMin Xuhong

Anhui Chest Hospital

352653531@qq.com+86 13855179548

Outcome results

None listed

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