NCT04973293Recruiting
Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer
The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 Jul 2021
- Start date
- Oct 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Ruijin Hospital
- Diseases
- Lung cancer
- NCT number
- NCT04973293
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Oct 2022 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;
- Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;
- Patients who have received prior treatment for non-small cell lung cancer;
Other illness
- Patients with active autoimmune disease or history of autoimmune disease;
- Patients with a history of symptomatic interstitial lung disease;
- History of allergy to study drug components;
- Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;
- Patients with high risk of major bleeding;
- Patients who have prior malignancies;
- HIV, HBV, HCV infection or active pulmonary tuberculosis;
- 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.
Other
- Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;
- Women must not be pregnant or breast-feeding;
- Men with female partners that are not willing to use contraception;
- Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;
- Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;
Who the study is looking for
- 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);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;
- Patients approve and sign the informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.