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Nanocrystalline Megestrol Acetate for Cachectic Stage Locally Advanced Hepatocellular Carcinoma

ConditionsCachexiaHepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

This study is a prospective, randomized, parallel-controlled clinical trial. The primary objective is to evaluate the superiority and safety of nanocrystalline megestrol acetate in combination with standard therapy compared with standard therapy alone in improving appetite and body mass index (BMI) during treatment in patients with early-stage or locally advanced hepatocellular carcinoma at the cachexia stage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with hepatocellular carcinoma who have not previously received systemic therapy and are confirmed by histological or cytological assessment, as evaluated by the investigator, to be unsuitable or ineligible for curative surgical resection; Barcelona Clinic Liver Cancer (BCLC) stage B-C.

Child-Pugh class A or B7.

Planned to receive interventional therapy in combination with systemic antitumor therapy.

At least one measurable tumor lesion according to mRECIST v1.1.

Disqualifiers

Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition.

Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult.

Patients with acquired immunodeficiency syndrome (AIDS).

Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nanocrystalline Megestrol Acetate

    Drug

    Nanocrystalline Megestrol Acetate oral suspension, with a specification of 125 mg/mL, administered orally at a dose of 5 mL per day (625 mg/day), and the primary endpoint efficacy collection will be conducted in the 4th week.

  • Standard Antitumor Therapy

    Combination product

    Standard Antitumor Therapy

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor TherapyExperimental treatment 2 interventions
Group B: Standard Antitumor TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of subjects with improved appetite based on A/CS-12 assessment.

Time frame
The proportion of subjects with improved appetite based on A/CS-12 assessment in 12 weeks

Secondary outcomes

1

Proportion of patients with BMI increase

Time frame
Proportion of patients with BMI increase in 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: