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Short-term efficacy evaluation and safety analysis of amlotinib combined with carrilizumab in second-line treatment of advanced lung cancer

Short-term efficacy evaluation and safety analysis of amlotinib combined with carrilizumab in second-line treatment of advanced lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047619
Enrollment
Unknown
Registered
2021-06-20
Start date
2021-06-21
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

lung cancer

Interventions

experimental group:amlotinib combined with carrilizumab

Sponsors

Ganyu District People's Hospital of Lianyungang City
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for advanced lung cancer, and the TNM stage is III B or IV; 2. KPS score >= 70 points; 3. The genetic test result is negative or unknown; 4. PD-L1 detection TPS >= 1% or unknown; 5. Have not used anti-angiogenesis drugs before; 6. The expected survival period is more than 3 months; 7. Disease progression after first-line chemotherapy with platinum-containing regimen (disease progression after first-line chemotherapy with EP/EC regimen, and CPT-11 intolerance or refusal of chemotherapy for second-line use).

Exclusion criteria

Exclusion criteria: 1. Central or cavitary squamous cell carcinoma, or accompanied by hemoptysis (the volume of hemoptysis> 50 ml/d); 2. Imaging shows that the tumor invades important blood vessels, or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 3. Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, central squamous cell carcinoma with cavity formation; 4. Those with serious heart, liver and kidney diseases; 5. Patients with malignant pleural effusion, pericardial effusion or superior vena cava compression syndrome; 6. Severe infection or other malignant tumors.

Design outcomes

Primary

MeasureTime frame
Adverse Event, Serious Adverse Events;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;Disease control rate;Objective remission rate;

Countries

China

Contacts

Public ContactJi Jun'an

The Second People's Hospital of Lianyungang

617778228@qq.com+86 18936570058

Outcome results

None listed

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