- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520853
SBRT Combined With PD-1 Inhibitor and Thoracic Hyperthermia for Advanced NSCLC
An Open, Single-arm, Multicenter Phase II Trial to Evaluate SBRT Combined With PD-1 Inhibitors and Thoracic Hyperthermia for Advanced Non-Small-Cell Lung Cancer
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Bing Xia, MD
- Phone Number: 86-0571-56006382
- Email: bxia_hzch@hotmail.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310002
- Recruiting
- Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine
-
Contact:
- Bing Xia, MD
- Phone Number: 86-0571-56006382
- Email: bxia_hzch@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1.Age≥18.
- 2.ECOG PS 0-1.
- 3.Histopathologically confirmed stage IV non-small-cell lung cancer.
- 4.EGFR/ALK/ROS-1 negetive.
- 5.Disease progression after first-line therapy including platinum chemotherapy, but not include PD-1/L1 inhibitors.
- 6.Subjects with brain metastases were eligible, but only if they had no neurologic symptoms or disease stable without systemic glucocorticoid.
- 7.At least one lesion with a diameter of 1-5cm which could be treated with SBRT at a dose of 32Gy/4Fx, and at least one lesion which could be measured other than SBRT (RECIST1.1); Lymph nodes can be used as independent measurable lesions or receive SBRT. Brain lesions should not be used as separate SBRT lesions or as measurable lesions.
- 8.The subjects did not had radiotherapy before.
- 9.The subjects did not currently need palliative radiotherapy at any part according to the researchers.
- 10.It was necessary for the subjects who underwent surgery to fully recover from the toxicity and complications caused by surgical intervention prior to treatment.
- 11.Subjects should provide appropriate biopsy specimens before and during treatment according to the clinical trial protocol.
- 12.Male or female subjects agree to contraception during the trial (surgical ligation or oral contraceptive/IUD + condom).
- 13.Life expectancy ≥ 3 months.
14.The organ function level meet the following standards one week before enrollment:
①Bone marrow: hemoglobin ≥80g/L, white blood cell count ≥4.0*10^9/L or neutrophil count ≥1.5*10^9/L, platelet count ≥100*10^9/L.
②Liver: Serum total bilirubin level ≤1.5 upper limit of normal (ULN), when serum total bilirubin level > 1.5 ULN, direct bilirubin level must be ≤ ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN.
③ Kidney: serum creatinine level < 1.5 ULN or creatinine clearance rate ≥ 50ml/min, urea nitrogen ≤ 200mg/L; Serum albumin ≥ 30g/L.
- 15. Subjects must be able to understand and voluntarily sign informed consent.
Exclusion Criteria:
- 1.Prior treatment with anti-PD-1 /L1 drugs or other investigational immunotherapy agent.
- 2.Subjects had prior radiotherapy.
- 3.Subjects had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc.
- 4.Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia.
- 5.Subjects had risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other risk factors for bowel perforation.
- 6.History of other malignant tumors.
- 7.Subjects who have current infection, heart failure, heart attack, unstable angina, or unstable arrhythmia in the last 6 months.
- 8.Subjects with physical examination or clinical trial findings, or other uncontrolled conditions that the investigator believes may interfere with the outcome or increase the risk of treatment complications.
- 9.Subjects without platinum-based combination chemotherapy included as first-line treatment.
- 10.The pathology reports showed a mixture of small cell lung cancer components.
- 11.Lactating or pregnant women.
- 12.Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or a history of organ transplantation, allogeneic stem cell transplantation.
- 13.Known hepatitis B virus (HBV), hepatitis C virus (HCV), active pulmonary tuberculosis infections.
- 14.Subjects had cancer vaccines other vaccines within 4 weeks before treatment initiation. (Seasonal influenza vaccines are usually inactivated and are permitted, whereas intranasal preparations are usually live attenuated vaccines and therefore are not permitted)
- 15.Subjects who currently use other immune agents, chemotherapy agents, other investigational drugs or long-term cortisol therapy.
- 16.Subjects with mental illness, substance abuse, and social problems that affected compliance were not included in the study according to doctor's evaluation.
- 17.Allergic or contraindicated to PD-1 inhibitors.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SBRT combined with PD-1 inhibitors and thoracic hyperthermia
At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx.
SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week.
PD-1 inhibitor was used on the second day after the completion of SBRT.
The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression.
|
At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx.
SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week.
PD-1 inhibitor was used on the second day after the completion of SBRT.
The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: 2 years
|
The proportion of patients evaluated as complete response or partial response
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-related toxic effects
Time Frame: 2 years
|
The proportion of treatment-related toxicity cases to the total number of evaluable cases assessed according to CTCAE 5.0 criteria
|
2 years
|
Objective response rate of non-irradiated lesions
Time Frame: 2 years
|
The proportion of patients with non-irradiated lesions evaluated as complete response or partial response in the total enrolled patients
|
2 years
|
Overall response
Time Frame: 2 years
|
The time span from the first day of enrollment until death from any cause
|
2 years
|
Progression free survival
Time Frame: 2 years
|
The time span from the first day of enrollment until progression or death from any cause
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bing Xia, MD, Hangzhou Cancer Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBRT-PT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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