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| Name | Class |
|---|---|
| Hangzhou Cancer Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT combined with PD-1 inhibitors and thoracic hyperthermia | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT combined with PD-1 inhibitors and thoracic hyperthermia | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | The proportion of patients evaluated as complete response or partial response | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related toxic effects | 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xia, MD | Contact | 86-0571-56006382 | bxia_hzch@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xia, MD | Hangzhou Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310002 | China |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
The proportion of patients with non-irradiated lesions evaluated as complete response or partial response in the total enrolled patients
| 2 years |
| Overall response | The time span from the first day of enrollment until death from any cause | 2 years |
| Progression free survival | The time span from the first day of enrollment until progression or death from any cause | 2 years |
| D014947 | Wounds and Injuries |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |