Health TrialsbyHealthPanel

Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors

ConditionsCachexiaDigestive System CancerGastric CancerColorectal CancerHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

This study is a prospective, observational clinical study aimed at evaluating the efficacy of Megestrol Acetate for cachexia in patients with advanced digestive system tumors receiving TKI-based therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign a written informed consent (ICF).

Age ≥ 18 years at enrollment.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Life expectancy ≥ 3 months.

Disqualifiers

Gastrointestinal obstruction.

Anorexia due to difficulty in eating caused by neurosis, mental illness, or pain.

Comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases.

Major surgery or trauma within the last month.

Trial population

Patients with locally advanced or metastatic digestive system tumors

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Nano-crystalline Megestrol Acetate Oral Suspension

    Drug

    Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day)

  • TKI-Based Therapy

    Drug

    TKI-Based Therapy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy2 interventions
Group B: TKI-Based Therapy1 intervention

Trial outcomes

Primary outcomes

1

Appetite improvement level

Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment

Time frame
From baseline to Week 12 (end of treatment period)
2

Weight improvement level

Proportion of subjects who did not lose weight relative to baseline after 12 weeks of treatment

Time frame
From baseline to Week 12 (end of treatment period)

Secondary outcomes

1

progression-free survival (PFS)

defined as the duration from the start treatment to progression, or patient death

Time frame
From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first，assessed up to 24 months

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
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