NCT05097781招募中2 期
Evaluating the Efficacy of Local Radiotherapy in Combination With Immunotherapy in Advanced Solid Tumors: a Phase II Prospective Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- non-irradiated lesion control rate(NRCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Patients must have failed to respond to at least one prior standard of care regimen
- •The patient must not have a conventional treatment option that is clinically proven to provide long-term control of the disease and the patient refuses other conventional treatment options
- •The patient is intolerant to the toxic side effects of the standard treatment regimen
- •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)
排除标准
- •Uncontrolled brain metastases (stabilization time <6 weeks)
- •Bone metastases alone without clear soft tissue mass formation
- •Bone marrow infiltration
- •Presence of clinical factors (e.g., bleeding, active infection, or psychiatric factors) that the investigator determines may interfere with the completion of the study process
- •Inability to administer radiotherapy due to organ-threatening or other factors as assessed by the investigator
- •Patients requiring long-term maintenance steroid therapy (including oral, intravenous use); topical use or inhalation may be included in the study
- •Prior autoimmune disease or active disease [e.g., including but not limited to inflammatory bowel disease [IBD], rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (e.g., Guillain-Barre syndrome)], vitiligo and correctable endocrine deficiencies such as thyroid hypofunction, physiological cortisol hypersecretion may be included in the study and are not considered as exclusion criteria.
- •history of active tuberculosis or non-infectious pneumonia or any clinical evidence
- •Active viral hepatitis with HBV DNA > 500 IU/ml
- •Immunodeficiency syndrome
- •comorbid serious medical disorders with concomitant diseases or conditions affecting the normal enrollment of the patient or safety during the study
- •previous immunotherapy for other tumors
- •History of other malignancies within 5 years (except cured basal cell carcinoma of the skin);
- •Pregnant or lactating women;
- •Unable or unwilling to sign the informed consent form.
研究组 & 干预措施
Treatment arm
Experimental
Local irradiation + immunotherapy
干预措施: PD-1 blocking antibody (Drug)
结局指标
主要结局
non-irradiated lesion control rate(NRCR)
时间窗: 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
The percentage of non-irradiated target lesions with CR/PR or SD
Objective response rate
时间窗: 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
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)
次要结局
- Progression free survival(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(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(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)
研究者
Jiayi Chen
Chief of Department of Radiation Oncology
Ruijin Hospital
研究点 (1)
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