Neoadjuvant and adjuvant therapy of immunization combined with chemotherapy in stage IIIA non-small cell lung cancer and explore biomakers of stage IIIA non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900025813

Enrollment

Unknown

Registered

2019-09-09

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-09-16

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:Sintilimab combined with chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years, gender is not limited; (2) Patients with stage IIIA NSCLC diagnosed by pathology; (3) According to the evaluation criteria of solid tumors, the RECIST standard demands that patients have clear measurable and evaluable lesions, spiral CT or MRI assessment of lesions must be 1CM; through clinical examination or other imaging studies must be 2CM; (4) Physical status score ECOG 0-1 points, KPS70 points; (5) Estimated survival of more than 3 months, easy to follow-up studies; (6) EGFR, ALK, ROS1 gene test results were wild type; (7) No other tumor history, cured cervical carcinoma in situ, skin basal cell carcinoma or scale; (8) Women of childbearing age have negative pregnancy test and voluntarily adopt effective and reliable contraceptive measures during clinical trials; (9) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who have recently received anti-tumor treatment (such as radiotherapy, chemotherapy, immunotherapy, surgery, etc.); (2) Those who are receiving immunosuppressive drugs; (3) Those who have received organ transplants; (4) Blood system, liver and kidney Impaired function. The evaluation criteria were as follows: blood routine: WBC 1.0 times of the upper limit of normal value; BUN> 1.5 times of the upper limit of normal value; Cr> 1.5 times of the upper limit of normal value; 1.5 times of upper limit of ALT and AST> normal value; (5) Those who have had severe allergic reactions to drugs in the past; (6) Clinical manifestations of significant arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve disease subjects; (7) Active autoimmune diseases; (8) Subjects with uncontrollable psychosis; (9) Pregnant or lactating subjects; (10) Subjects who are considered unfit for this study.

Design outcomes

Primary

Measure	Time frame
PD-L1;ki67;	—

Countries

China

Contacts

Public ContactZhou Xiaorong

Nantong University

zhouxiaorong@ntu.edu.cn+86 13861948117

Outcome results

None listed

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