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The prospective, non-interventional clinical study of carelizumab combined with apatinib in the second-line treatment of advanced non-small cell lung cancer

The prospective, non-interventional clinical study of carelizumab combined with apatinib in the second-line treatment of advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034455
Enrollment
Unknown
Registered
2020-07-05
Start date
2020-07-03
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

lung cancer

Interventions

Sponsors

The Affiliated Tumor Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The subjects volunteered to join the study, signed the informed consent, had good compliance and cooperated with the interview; 2. Patients aged >=18 years old to 75 years old on the day of signing informed consent; 3. Patients with advanced / recurrent non-small cell lung cancer diagnosed by histopathology and / or cytology who have received one systematic treatment; 4. Patients with at least one measurable lesion (recist1.1) and a history of treatment with any of the systemic anticancer drugs.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. For the target observation group, the following patients with immune system diseases and lung diseases were excluded: (1) Patients with active autoimmune diseases; (2) Patients with a history of chronic or recurrent autoimmune diseases; (3) Patients with interstitial lung disease or pulmonary fibrosis; (4) Patients with a history of pneumonia treated with glucocorticoids; 3. Patients with a history of gastrointestinal hemorrhage or with a clear tendency of gastrointestinal bleeding in the past 6 months, such as esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood = + +, can not be included in the group; if fecal occult blood (+), gastroscopy is required; 4. Patients who had abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days before participating in this study; 5. Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 6. The patients whose urine routine showed urine protein >=+ + + or confirmed 24-hour urine protein quantity > 1.0g; 7. Patients who had received strong CYP3A4 inhibitor treatment within 7 days before the study, or received strong CYP3A4 inducer treatment within 12 days before participating in the study; 8. According to the judgment of the researcher, there are accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactRuiling Ning

The Affiliated Tumor Hospital of Guangxi Medical University

rlning@163.com+86 13517662412

Outcome results

None listed

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