Clinical trial · Observational
Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in TKI-Treated Advanced Digestive Tumors
A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy
NCT06940102CI-TRIAL-00088827recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Digestive System Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | — | UNRESOLVED |
| TKI-Based Therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy
- description
- 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 Therapy ± chemotherapy / immunotherapy
- interventionNames
- Drug: Nano-crystalline Megestrol Acetate Oral Suspension
- Drug: TKI-Based Therapy
- label
- TKI-Based Therapy
- description
- TKI Therapy ± chemotherapy / immunotherapy
- interventionNames
- Drug: TKI-Based Therapy
Primary outcomes (2)
- measure
- Appetite improvement level
- timeFrame
- From baseline to Week 12 (end of treatment period)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition TNM staging classification. * Not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive TKI-based anticancer treatment, which may be combined with chemotherapy or immunotherapy). * Meet the diagnostic criteria for pre-cachexia or cachexia (based on Fearon diagnostic criteria). * Good organ function determined Exclusion Criteria: * 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. * Allergy to any component of the investigational drug. * Other conditions deemed unsuitable by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.