Evaluating the Efficacy of Local Radiotherapy in Combination With Immunotherapy in Advanced Solid Tumors: a Phase II Prospective Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- PD-1 blocking antibody
- Conditions
- Solid Tumor
- Sponsor
- Ruijin Hospital
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- non-irradiated lesion control rate(NRCR)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Jiayi Chen
Chief of Department of Radiation Oncology
Ruijin Hospital
Eligibility Criteria
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:
Exclusion Criteria
- •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
Arms & Interventions
Treatment arm
Local irradiation + immunotherapy
Intervention: PD-1 blocking antibody
Outcomes
Primary Outcomes
non-irradiated lesion control rate(NRCR)
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
- 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)