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This is a phase II study to observe efficacy of combining local radiotherapy with PD-1blockade in patients with advanced solid tumors. All patients will accept at least one site of radiotherapy together with PD-1 blockade. The study will evaluate changes of unirradiated and irradiated lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Local irradiation + immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 blocking antibody | Drug | All patients with more than one distant metastatic lesions will accept at least one site of radiotherapy and PD-1 blockade at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of patients with a tumor volume reduction of 30% lasting for at least 4 weeks,and is the sum of the proportion of complete remission (CR) and partial remission (PR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed at least 4 weeks |
| non-irradiated lesion control rate(NRCR) | The percentage of non-irradiated target lesions with CR/PR or SD | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | The time from enrollment to disease progression or death from any cause | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| Overall survival |
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Inclusion Criteria:
Adult patients 18-75 years old with the right to make medical decisions
Signed informed consent form
ECOG score of 0-2
Clear pathological diagnosis of the primary site
Multiple distant metastases
Stable assessment of brain metastases after treatment can be enrolled (more than 6 weeks)
Bone metastases combined with soft tissue mass formation can be enrolled
imaging with ≥ 2 clearly assessable lesions (bone metastases alone without soft tissue mass formation, brain metastases not as target lesions)
expected survival ≥ 6 months
Progression after ≥ 1 prior line of therapy regimen with no standard treatment regimen or intolerable toxicities, including all three of the following:
No prior immunotherapy history
Time to last systemic therapy (including monoclonal antibodies) ≥ 4 weeks
Previous radiotherapy to non-target sites with other evaluable lesions can be enrolled
Laboratory examination indexes meet the following requirements: WBC ≥ 3×109/L, ANC ≥ 2.0×109/L, PLT ≥ 80×109/L, Hb ≥ 80g/L (according to the normal standards of the central laboratory department); liver function: total bilirubin, ALT and AST are ≤ 1.5xUNL (upper limit of normal value); AST (SGOT)/ALT (SGPT) ≤ 2.5xUNL (upper limit of normal value) ALT (SGPT) ≤ 2.5 x IULN (upper limit of normal value); renal function: Cr≦1.5xUNL (upper limit of normal value), and creatinine clearance rate≧60ml/min; thyroid function T3, T4 within normal range (hypothyroidism can be supplemented with oral thyroxine); cardiac function: cardiac protein three and pro-BNP within normal range, no previous Adrenal function: normal cortisol secretion function or correctable by endocrine assessment
HBV infected patients with HBV-DNA copy number less than 500 IU/ml
No history of other malignancies within 5 years (except skin basal cell carcinoma)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujie Wang, MD | Contact | 8602164370045 | 602400 | wyj12054@rjh.com.cn |
| Yunsheng Gao, MD | Contact | gys11856@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiayi Chen, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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|
The time from enrollment to death from any cause |
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| Rate of side effects | ≥ grade 3 adverse effects | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |