Skip to content

Single-arm, prospective, exploratory clinical study of Carrizumab combined with thalidomide, Pemetrexed and carboplatin in the first-line treatment of advanced non-squamous cell non-small cell lung cancer

Single-arm, prospective, exploratory clinical study of Carrizumab combined with thalidomide, Pemetrexed and carboplatin in the first-line treatment of advanced non-squamous cell non-small cell lung cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038265
Enrollment
Unknown
Registered
2020-09-15
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Non-squamous cell lung cancer

Interventions

Single group:Carrizumab+ thalidomide + Pemetrexed + carboplatin

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with age >= 18 years, regardless of gender; 2. Patients with non-small cell lung cancer with advanced non squamous cell carcinoma confirmed by histopathology or cytology; 3. According to RECIST 1.1 standard, subjects must have measurable target lesions that have passed CT or MRI examination; 4. When the patients are enrolled, the WHO / ECoG score was 0 or 1; 5. Life expectancy >= 3 months; 6. Patients sign informed consent and voluntarily joined the study; 7. For patients without severe liver and kidney injury, the functional level of organs must meet the following requirements: ANC >= 1.5 x 10^9 / L; PLT >= 90 x 10^9 / L; HB >= 90 g / L; TBIL = 50 ml / min (Cockcroft Gault formula); LVEF >= 50%; QTCF corrected by fridericia method < 450 ms, female< 470 msINR <= 1.5 x ULN, ACTT <= 1.5 x ULN.

Exclusion criteria

Exclusion criteria: 1. Patients who have received systemic chemotherapy for advanced (metastatic) diseases; 2. There is evidence that neoadjuvant chemotherapy or adjuvant cytotoxic chemotherapy (or both) is completed Patients with disease progression within 6 months after radiotherapy; 3. Patients with allergic or hypersensitive constitution and patients with autoimmune diseases; 4. Patients with third space effusion that cannot be controlled by drainage or other methods (e.g., massive pleural effusion) And ascites); 5. Patients who have been treated with steroids for more than 50 days or need to use steroids for a long time; 6. Patients with uncontrolled symptomatic brain metastases or mental disorders who can not correctly express subjective symptoms; 7. Patients receiving any other anti-tumor treatment at the same time, including anti-tumor Chinese patent medicine and immune preparation; 8. In patients with non swallowing, chronic diarrhea and intestinal obstruction, there are many kinds of drugs that affect the drug taking and absorption factor; 9. Patients with other malignant tumors within 5 years before enrollment were treated with radical therapy Cervical carcinoma in situ or skin squamous or basal cell carcinoma was excluded; 10. Pregnant and lactating women who have fertility but refuse to take contraceptive measures; 11. Patients with severe heart disease or history, including: documented congestive heart failure History, high-risk uncontrollable arrhythmia, angina pectoris requiring drug treatment, clinically confirmed heart valve disease, history of severe myocardial infarction and refractory hypertension; 12. Patients who have received allogeneic tissue / solid organ transplantation; 13. According to the judgment of the researcher, there are accompanying diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the safety of patients or affect patients to complete the study; 14. Other cases not suitable for inclusion in the study were determined by the researcher.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactHan Zhengxiang

Affiliated Hospital of Xuzhou Medical University

cnhzxq@163.com+86 18052268612

Outcome results

None listed

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