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Trial Title:
SBRT Combined With PD-1 Inhibitor and Thoracic Hyperthermia for Advanced NSCLC
NCT ID:
NCT05520853
Condition:
Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC
Conditions: Official terms:
Hyperthermia
Fever
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT combined with PD-1 inhibitors and thoracic hyperthermia
Description:
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.
Arm group label:
SBRT combined with PD-1 inhibitors and thoracic hyperthermia
Summary:
The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1
inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage
IV NSCLC patients who progressed after first-line treatment. 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. During the period, the overall response rate and toxicities were
regularly evaluated.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310002
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xia, MD
Phone:
86-0571-56006382
Email:
bxia_hzch@hotmail.com
Start date:
January 20, 2020
Completion date:
December 31, 2024
Lead sponsor:
Agency:
First People's Hospital of Hangzhou
Agency class:
Other
Collaborator:
Agency:
Hangzhou Cancer Hospital
Agency class:
Other
Source:
First People's Hospital of Hangzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520853