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

NCT03777930 | Unknown Phase 4 DMC

• 1 other identifier: shenzhenfifth 201807
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cancer, Therapy-Related

Keywords

thalidomide; megestrol acetate; tumor; lymphocyte; inflammatory cytokines; nutritional

Outcome Measures

Primary Outcomes (1)

• Imaging efficacy evaluation

  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.

  before and 8 week after treatment

Secondary Outcomes (3)

• Observing the expression of lymphocyte subsets

  before , the fourth and the seventh weeks of treatment

• Observing the expression of inflammatory factors

  before , the fourth and the seventh weeks of treatment

• Nutritional assessment

  before , the fourth and the seventh weeks of treatment

Other Outcomes (6)

• Multidimensional deficient power assessment

  before , the fourth and the seventh weeks of treatment

• Quality of life assessment

  before , the fourth and the seventh weeks of treatment

• Prognostic assessment

  before , the fourth and the seventh weeks of treatment

Study Arms (4)

chemotherapy group

EXPERIMENTAL

the patients were recepted chemotherapy alone

Drug: Chemotherapy drugs

chemotherapy combined with TH and MG group

EXPERIMENTAL

the patients were recepted chemotherapy combined with thalidomide and megestrol

Drug: thalidomide and megestrol acetate

the best supportive treatment group

EXPERIMENTAL

the patients were recepted the best supportive without chemotherapy

Other: optimal support treatment

the best supportive treatment combined with TH and MG group

EXPERIMENTAL

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

Drug: thalidomide and megestrol acetate

Interventions

Chemotherapy drugs DRUG

According to the NCCN Guidelines

chemotherapy group

thalidomide and megestrol acetate DRUG

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

Also known as: Chemotherapy drugs

chemotherapy combined with TH and MG group

optimal support treatment OTHER

Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks

the best supportive treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Shenzhen Fifth People's Hospital: lead

MeSH Terms

Conditions

Neoplasms, Second Primary; Neoplasms

Interventions

Antineoplastic Agents; Thalidomide; Megestrol Acetate

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

yangwei w yang, master

CONTACT

13826524554; junweiyang@163.com

wenbin wb gao, doctor

CONTACT

13266778968; drwenbingao@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 200 patients with advanced tumors with a predicted survival period of ≥2 months were selected, including 100 patients with chemotherapy indications (50 patients were divided into chemotherapy group and 50 patients were divided into chemotherapy combined with TH and MG group according to the random principle) and 100 patients without chemotherapy indications (50 patients were randomly divided into the best supportive treatment group and 50 patients were randomly divided into the best supportive treatment group with TH and MG according to the random principle). The chemotherapy alone group and the best supportive treatment group were the control group. 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.

Study Record Dates

• First Submitted: August 25, 2018
• First Posted: December 19, 2018
• Study Start: December 10, 2018
• Primary Completion: October 10, 2020
• Study Completion: June 10, 2021
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share