NCT04973293 Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
| NCT ID | NCT04973293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ruijin Hospital |
| Condition | Lung Neoplasm Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-10-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included); 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 3. Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery; 4. Patients approve and sign the informed consent. Exclusion Criteria: 1. Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma; 2. Patients with active autoimmune disease or history of autoimmune disease; 3. Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications; 4. Patients with a history of symptomatic interstitial lung disease; 5. History of allergy to study drug components; 6. Women must not be pregnant or breast-feeding; 7. Men with female partners that are not willing to use contraception; 8. Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy; 9. Patients who have received prior treatment for non-small cell lung cancer; 10. Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information; 11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels; 12. Patients with high risk of major bleeding; 13. Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures; 14. Patients who have prior malignancies; 15. HIV, HBV, HCV infection or active pulmonary tuberculosis; 16. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
Contact & Investigator
Hecheng Li, MD, PhD
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT04973293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Neoplasm Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04973293 currently recruiting?
Yes, NCT04973293 is actively recruiting participants. Contact the research team at lihecheng2000@hotmail.com for enrollment information.
Where is the NCT04973293 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04973293 clinical trial?
NCT04973293 is sponsored by Ruijin Hospital. The principal investigator is Hecheng Li, MD, PhD at Ruijin Hospital. The trial plans to enroll 20 participants.