An Observational Study on the Efficacy and Safety of Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

This is a prospective, single-center observational clinical study aimed at the efficacy and safety of radiotherapy combined with PD-1 inhibitors and chemotherapy in the treatment of Chinese patients with symptomatic NSCLC with brain metastases.

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

⁃ 1\. Age ≥ 18 years old; patients with metastatic NSCLC with at least one measurable brain metastases, the longest diameter of the brain metastases is 0.5 to 3 cm, and the brain metastases have not received radiotherapy; stable neurological symptoms and/or are receiving Corticosteroid therapy. In addition, the following conditions are raised:

• Patients with negative driver-gene mutations who have not received systemic treatment before, and patients who have progressed after receiving neoadjuvant or adjuvant therapy, and the interval between disease progression or recurrence and the end of the last chemotherapy drug treatment is at least 6 months, and is allowed to enter this study;

• Patients with known EGFR sensitive mutation, ALK rearrangement or ROS1 fusion must have received at least one EGFR or ALK, ROS1 fusion inhibitor treatment and had disease progression or drug intolerance.

• Subjects with neurological symptoms can receive dexamethasone within 10 days before the first treatment, but the total daily dose is stable at no more than 4 mg or other Corticosteroids at the same dose. Subjects with neurologic symptoms but not receiving steroids should experience no seizures within 10 days prior to first treatment.

⁃ 2\. For patients with non-brain oligometastases, according to Response Evaluation Criteria in Solid Tumors Version 1.1 (mRECIST v1.1), there is at least 1 measurable or evaluable lesion in addition to brain metastases.

⁃ 3\. The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score) is 0-2 points.

⁃ 4\. The patient has a clear mind, can answer correctly, and has basically normal vision, etc., and can cooperate with cognitive function assessment 5. Expected survival time ≥ 12 weeks. 6. The patient has adequate organ and bone marrow functions, as defined below:

• Blood routine: absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin content ≥9.0 g/dL.

• Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with HCC, liver metastases, or a history/suspect of Gilbert syndrome (persistent or recurrent hyperbilirubinemia , mainly high unconjugated bilirubin, no evidence of hemolysis or liver disease), TBIL ≤ 3 × ULN; for patients without HCC and liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with HCC or with liver metastases, ALT or AST ≤ 5 × ULN.

• Renal function: serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (CCr) ≥ 50mL/min; urine test paper test results show urine protein \<2+.

• Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN.

Locations
Other Locations
China
Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Rongrong Zhou
zhourr@csu.edu.cn
+86 13875898127
Time Frame
Start Date: 2021-12-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Group 1
Sponsors
Leads: Xiangya Hospital of Central South University
Collaborators: Wu Jieping Medical Foundation

This content was sourced from clinicaltrials.gov

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