Status:
UNKNOWN
PraG With RANKL Inhibitor for the Treatment of Advanced Multiple Metastatic Solid Tumors
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Metastatic Solid Tumor
Eligibility:
All Genders
18+ years
Brief Summary
The PraG treatment model has synergistic effects with RANKL inhibitor therapy, and the combination of the two treatments provides a survival benefit for patients with multiple bone metastatic solid tu...
Detailed Description
Group A(6 patients):patients were subcutaneously injected with 120mg desomumab, and on the second day after injection, the metastatic lesions were treated with hypofractioniated radiotherapy (8Gy×3F o...
Eligibility Criteria
Inclusion
- Aged≥18 years
- The patients must conform to the advanced solid cancer with multiple metastases(may be accompanied by metastasis of other organs),progression after first-line systemic therapy and have clear pathological diagnosis report
- The hematopoietic function and general condition of the patients were acceptable(white blood cells \>2.5×10\^9/L,lymphocyte\>0.5 times of normal lower limit，Platelets\>50×10\^9/L）
- There was no history of serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency
- One week before enrollment,absolute value of T lymphocytes≥0.5 times of normal lower limit，neutrophil ≥ 1.0×109/L，AST and ALT ≤3.0 times normal upper limit(Liver cancer/liver metastasis patients ≤5.0 times normal upper limit);creatinine ≤ 3.0 times normal upper limit;serum calcium≥2.0mmol/L
- Patients's activity status was assessed by Eastern Cooperative Oncology Group(ECOG) score of 0-3,and life expectancy of more than 3 months
- Abide by the plan during the study period
- Sign written consent
Exclusion
- Pregnant or lactating women
- Patinets diagnosed with other malignant disease in the past five years,except for cured skin cancer and cervical carcinoma in situ
- The clinical severity of uncontrolled epilepsy,central nervous system disease or mental disorder may hinder the signing of informed consent or affect the patient's compliance with medication
- Sever(i.e. active)heart disease,such an symptomatic coronary heart disease,New York Heart Association(NYHA) class Ⅱ or more severe congestive heart failure or severe arrhythmia requiring drug intervention,or a history of myocardial infraction in the last 12 months；
- Organ transplantation require immunosuppressive therapy
- Major active infections are known,or other serious uncontrolled concomitant diseases;endocrine or metabolic disorders,or other serious uncontrolled concomitant diseases;
- The baseline blood routine did not meet the following criteria:hemoglobin≥90g/L;absolute neutrophil count(ANC)≥1.5×109/L;platelet≥50×109/L;ALT,AST≤2.5 times normal upper limit value;ALP≤2.5 times normal upper limit value; serum total bilirubin\<1.5 times normal upper limit value;Serum creatinine \<3 times normal upper limit value;serum albumin≥30g/L;
- Anaphylaxis to any research drug ingredients
- Patients with a history of immunodeficiency,including HIV postive or with other acquired or congenital immunodeficiency disorders,or with a history of organ transplantation,or with other immune-related diseases requiring long-term oral hormone therapy
- In the period of acute and chronic tuberculosis infection (T-spot test positive,chest X-ray suspicious tuberculosis focus patients)
- Researchers considered that it was not suitable for other situations in the group
Key Trial Info
Start Date :
August 16 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 15 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05435768
Start Date
August 16 2022
End Date
August 15 2025
Last Update
August 18 2022
Active Locations (1)
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1
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004