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

Shenzhen Fifth People's Hospital

Status and phase: Unknown; Phase 4

Conditions: Cancer, Therapy-Related

Treatments: Other: optimal support treatment; Drug: Chemotherapy drugs; Drug: thalidomide and megestrol acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT03777930

shenzhenfifth 201807

Details and patient eligibility

About

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 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

chemotherapy group

Experimental group

Description:

the patients were recepted chemotherapy alone

Treatment:

Drug: Chemotherapy drugs

chemotherapy combined with TH and MG group

Experimental group

Description:

the patients were recepted chemotherapy combined with thalidomide and megestrol

Treatment:

Drug: thalidomide and megestrol acetate

Drug: thalidomide and megestrol acetate

the best supportive treatment group

Experimental group

Description:

the patients were recepted the best supportive without chemotherapy

Treatment:

Other: optimal support treatment

the best supportive treatment combined with TH and MG group

Experimental group

Description:

the patients were recepted the best supportive combined with thalidomide and megestrol without chemotherapy

Treatment:

Drug: thalidomide and megestrol acetate

Drug: thalidomide and megestrol acetate