Non-Small Cell Lung Cancer
Conditions
Brief summary
The aim of this clinical trial is to understand whether spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment is effective in treating initially unresectable stage Ⅲ non-small cell lung cancer (NSCLC). It will also explore the safety of this treatment modality. The main questions it aims to answer are: Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?
Detailed description
Research Title: A Clinical Study on Induction Treatment with Spatial Fractionated Radiotherapy (SFRT) Concurrent with Tislelizumab Plus Platinum-based Doublet Chemotherapy for Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Research Objective: To explore the efficacy and safety of induction treatment with spatial fractionated radiotherapy (SFRT) concurrent with tislelizumab plus platinum-based doublet chemotherapy for initially unresectable stage III non-small cell lung cancer (NSCLC). Design Type: Interventional Study Research Subjects: Patients with non-small cell lung cancer diagnosed by pathological histology or cytology, staged as stage III (T3 - 4N1 - 2M0) according to the 8th edition of AJCC, defined as initially unresectable by the multidisciplinary team (MDT), without known EGFR and ALK mutations, aged ≥ 18 years old, with an ECOG PS score of 0 - 1. Sample Size: 30 cases
Interventions
Several spherical volumes (with a diameter of 1 cm) are selected within the hypoxic area of the primary tumor. The distance between each spherical volume is 1.5 - 2 cm, and a high-dose radiotherapy of 12 Gy × 1F is delivered.
For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.
For NSCLC with pathological types other than adenocarcinoma, nab-paclitaxel (100 mg/m² on day 1 and day 8) + carboplatin (AUC 5, day 1) is used.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The patient has histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) that is deemed unresectable after discussion in the multidisciplinary team (MDT), which is classified as T3-4N1-2M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC).
Exclusion criteria
* Has participated in another clinical study using research products within the past 3 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical resection rate | At the end of the surgery | The percentage of patients who underwent surgical resection after induction treatment |
Countries
China
Contacts
CONTACTjing cai Jing Cai
Outcome results
None listed