Refractory Tumor Clinical Trial
Official title:
Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)
This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Malignant solid tumors diagnosed histologically; - Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment; - Expected survival = 1 month; - ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB = 90g / L, ANC = 1.5 × 109 / L, PLT = 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr = 1 × ULN, endogenous creatinine clearance =50ml/min Exclusion Criteria: - Patient still has standard treatment therapy based on NCCN guidance; - Patient can not comply with research program requirements or follow-up; |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changzheng Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Baodong Qin |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate | Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission | Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months | |
Secondary | Progress Free Survival | Time from treatment beginning until disease progression | Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months | |
Secondary | Overall Survival | Time from treatment beginning until death from any cause | From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months | |
Secondary | Adverse Effect | Incidence of Treatment-related adverse Events | Through study completion, an average of 1 months |
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