A Phase I Dose Escalation Study of Thoracic Consolidation Radiotherapy for Extensive-stage Small Cell Lung Cancer Patients Treated With Chemo-immunotherapy

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study intends to recruit ES-SCLC patients with response to standard first-line chemo-immunotherapy to assess the safety of receiving different doses of consolidative thoracic radiotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age ≥ 18 years;

• ECOG performance status score 0-2 points;

• pathologically confirmed small cell lung cancer;

• complete baseline imaging data (including brain enhanced MRI/CT, PET-CT or chest enhanced CT + bone scan + neck and abdominal B ultrasound/CT) before first-line treatment;

• stage extensive-stage SCLC at initial diagnosis, and first-line treatment received standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1) for at least 4 cycles after the efficacy assessment of SD or PR (residual lesions assessed by chest CT);

• no history of other malignancies;

• reproductive age male/female agreed to contraception during the trial (surgical ligation or oral contraceptives/intrauterine devices + condom contraception);

• life expectancy ≥ 3 months

• 1 week before enrollment, the investigator judged that the patient could continue immune maintenance therapy at the same time, And the organ function level meets the following criteria:

⁃ 1\) bone marrow function: hemoglobin ≥ 80 g/L, white blood cell count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L; 2) liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, when serum total bilirubin level \> 1.5 times the upper limit of normal direct bilirubin level must be ≤ the upper limit of normal,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times of the upper limit of normal; serum albumin ≥ 27 g/L; 3) Kidney: serum creatinine level \< 1.5 times of the upper limit of normal or creatinine clearance ≥ 50 ml/min, urea nitrogen ≤ 200 mg/L; 10.Patients must have the ability to understand and voluntarily sign an informed consent form.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xiao Chu
chuxiao@sibs.ac.cn
15821383376
Backup
Huang Chen
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 28
Treatments
Experimental: Starting Dose, Arm 1
For ES-SCLC patients who completed first-line four-cycle chemo-immunotherapy, and was evaluated to have any response to treatment. Thoracic radiotherapy is administered to treat residual thoracic lesions during immunotherapy maintenance phase. Thoracic radiotherapy should begin within 42 days after the end of the last chemotherapy at an initial dose of 30 Gy in 10 fractions (3 patients).
Experimental: Dose escalation 1, Arm 2
Dose escalation will start after acceptable safety was observed, first at: 35 Gy/10 Fx (3 patients). Radiotherapy was administered between two immunotherapy doses (3 weeks interval) to avoid thoracic radiotherapy on the same day with immunotherapy.~Immunotherapy was maintained until disease progression or the investigator 's judgment there was no further benefit from immunotherapy, patient died, intolerable toxicity developed. Toxicities were assessed periodically during the study. Local radiotherapy is permitted for symptomatic brain/bone metastases.
Experimental: Dose escalation 2, Arm 3
Dose escalation will continue after acceptable safety was observed in the previous dose gourp, at: 40 Gy/10 Fx (22 patients). Radiotherapy was administered between two immunotherapy doses (3 weeks interval) to avoid thoracic radiotherapy on the same day with immunotherapy.~Immunotherapy was maintained until disease progression or the investigator 's judgment there was no further benefit from immunotherapy, patient died, intolerable toxicity developed. Toxicities were assessed periodically during the study. Local radiotherapy is permitted for symptomatic brain/bone metastases.
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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