The Evaluation of Curative Effect on Treatment of Tumor Above Thalidomide Combined With Megestrol

Overview

To observe the effect of thalidomide combined with megestrol acetate on lymphocyte, inflammatory factor regulation and nutritional status in patients with advanced malignant tumors.

Full Title of Study: “Prospective Clinical Study of the Effect of Thalidomide Combined With Megestrol Acetate on Lymphocyte, Inflammatory Factor Regulation and Nutritional Status in Patients With Advanced Malignant Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 10, 2020

Detailed Description

This study was to select 200 patients with advanced tumors with an estimated survival of ≥ 2 months. 50 patients were randomly assigned to each group. The patients were divided into chemotherapy group, chemotherapy combined with thalidomide and megestrol acetate group, The best supportive treatment group, the best supportive treatment combined with thalidomide and megestrol acetate group. The chemotherapy group and the best supportive treatment group were the control group. The combined group was administered continuously for 8 weeks according to thalidomide 100 mg qn po and megestrol acetate 0.16 qd po. Calculating the sum of the longest diameters of the target lesions from each patient before and 8 week after treatment. Patients in each group before treatment, 4th week, and 7th week were observed T cell subsets, B cell subsets, NK cell subsets and the expression of inflammatory cytokines. Through nutritional assessment Table (PG-SGA), Multidimensional Deficit Power Meter (MFSI-SF), Quality of Life Assessment Scale (EORTC QLQ-C30), Prognostic Assessment Form (GPS), Physical Status Assessment Form (ECOG) and lean body mass, upper arm muscle circumference and upper arm muscle area analysis of the effect of thalidomide combined with megestrol acetate on the nutritional status of patients with advanced cancer which reveal that thalidomide combined with megestrol acetate may improve the immune regulation and nutritional status of patients with advanced malignant tumors mechanism.

Interventions

  • Drug: Chemotherapy drugs
    • According to the NCCN Guidelines
  • Drug: thalidomide and megestrol acetate
    • The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
  • Other: optimal support treatment
    • Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
  • Drug: thalidomide and megestrol acetate
    • The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks

Arms, Groups and Cohorts

  • Experimental: chemotherapy group
    • the patients were recepted chemotherapy alone
  • Experimental: chemotherapy combined with TH and MG group
    • the patients were recepted chemotherapy combined with thalidomide and megestrol
  • Experimental: the best supportive treatment group
    • the patients were recepted the best supportive without chemotherapy
  • Experimental: the best supportive treatment combined with TH and MG group
    • the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Imaging efficacy evaluation
    • Time Frame: before and 8 week after treatment
    • Clinical response Based on the Response Evaluation Criteria Solid Tumors (RECIST), the therapeutic effect was divided into complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD). Investigators calculate the sum of the longest diameter of the target lesions from each patient by CT or MRI.

Secondary Measures

  • Observing the expression of lymphocyte subsets
    • Time Frame: before , the fourth and the seventh weeks of treatment
    • Patients were detected Lymphocyte subgroups of 2 ml peripheral blood by Flow cytometer (BD FACSCalibur), which inclunde the T cell subsets, NK cell subset, B cell subset(percentage)
  • Observing the expression of inflammatory factors
    • Time Frame: before , the fourth and the seventh weeks of treatment
    • 2 ml of peripheral blood was taken from each patient. Flow cytometry was used to detect changes of inflammatory factor expression which include the IL-2, IL- 4, IL-5, IL-6, IL-9, IL-10, IL-13, IL-17A, IL-17F, IL-21, IL-22, IFN-γ and TNF-α(ug/ml)
  • Nutritional assessment
    • Time Frame: before , the fourth and the seventh weeks of treatment
    • Scored Patient-Generated Subjiective Global Assessment(PG-SGA)form was used in the present study. The total score of PG-SGA is summed by the following four subscale scores(A+B+C+D). The first measurement score(A)is self-assessed by the subject and consists of the following four parts: Weight Table(0-4),Eating Situation Table(0-6),Symptom Table (0-22),Activity and Body Function Table(0-3). The remaining three measurements are completed by trained registered clinical physicians, dieticians,and nurses: Scale of relationship between disease and nutritional needs(B)(0-6),Metabolic demand scale(C)(0-9),Physical examination scale(D)(0-24). The scoring was controlled by one researcher (H.R). The lower scores represent a better outcome and the higher scores represent a worse outcome.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with advanced malignant tumor confirmed by histopathology or cytology (hepatocarcinoma can be clinical diagnosis) – Must be able to swallow pills – The age of the tester ≥ 18 years old – Gender is not limited – Kamofsky score > 20 points – Estimated survival period ≥ 2 months – Childbearing age Women need negative pregnancy test – Patients voluntarily sign informed consent and receive follow-up – The tester can cooperate to observe adverse events and efficacy – All of the above conditions can be included Exclusion Criteria:

  • Active upper digestive tract ulcers, obvious vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc; other patients have been known to affect drug absorption, distribution, metabolism or clearance – 2 or more important organ dysfunction – Thrombosis Embolism history, except for thrombosis caused by PICC – Patients suspected of having a history of allergy to thalidomide tablets – Any significant clinical and laboratory abnormalities that researchers believe affect safety evaluators, such as: uncontrollable activity Microbial infection, grade II or above peripheral neuropathy (NCI CTC AE v4.0), congestive heart failure, myocardial infarction within 6 months, chronic kidney disease, thyroid dysfunction etc, and acceptance may bring significant metabolic or weight changes Patients with clinical disposition – Patients with mental disorders, affecting the efficacy of the assessor – During the trial period and within 3 months after the end of the trial, the subject and his partner are not willing to contraception – Any of the above can not be enrolled.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shenzhen Fifth People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • yangwei w yang, master, 13826524554, junweiyang@163.com

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