NCT04973293

Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer

Recruiting now NA Last updated 19 November 2024

What this trial tests

NA trial testing sintilimab in Lung Neoplasm Malignant in 20 participants. Currently enrolling.

Timeline

1 October 2022

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Ruijin Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 October 2022
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• sintilimab — full drug profile →
• bevacizumab (Bevacizumab-Bvzr) — full drug profile →

Conditions studied

• Lung Neoplasm Malignant — all drugs for Lung Neoplasm Malignant →

Sponsor

Ruijin Hospital

Who can join

Adults 18 to 75, any sex, with Lung Neoplasm Malignant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endothelial cells in tumor microenvironment: insights and perspectives.
   Leone P, Malerba E, Susca N, Favoino E, et al · · 2024 · cited 90× · PMID 38426109 · DOI 10.3389/fimmu.2024.1367875
2. Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
   Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676
3. Developments in targeted therapy & immunotherapy-how non-small cell lung cancer management will change in the next decade: a narrative review.
   Li MSC, Mok KKS, Mok TSK. · · 2023 · cited 37× · PMID 37675321 · DOI 10.21037/atm-22-4444
4. Combined pembrolizumab and bevacizumab therapy effectively inhibits non-small-cell lung cancer growth and prevents postoperative recurrence and metastasis in humanized mouse model.
   Qiao T, Zhao J, Xin X, Xiong Y, et al · · 2023 · cited 13× · PMID 36357599 · DOI 10.1007/s00262-022-03318-x
5. An Updated Review of Management of Resectable Stage III NSCLC in the Era of Neoadjuvant Immunotherapy.
   Verma S, Breadner D, Mittal A, Palma DA, et al · · 2024 · cited 10× · PMID 38610980 · DOI 10.3390/cancers16071302
6. Natural Killer Cell-Mediated Antitumor Immunity: Molecular Mechanisms and Clinical Applications.
   Luo N, Chen C, Zhou W, Hao J, et al · · 2025 · cited 2× · PMID 40959206 · DOI 10.1002/mco2.70387
7. Conversion therapy with immunotherapy plus chemotherapy achieves a pathological complete response in stage IIIC NSCLC.
   Fu Y, Duan W, Xu R, Chen J. · · 2023 · cited 1× · PMID 38022567 · DOI 10.3389/fimmu.2023.1268153
8. Tumor-associated endothelial cells in tumor immune escape and immunotherapy: multifaceted roles and treatment approaches.
   Zheng T, Yu X, Yu C, Xu W, et al · · 2025 · PMID 41444687 · DOI 10.1186/s40364-025-00883-y