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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension +TKI-Based Therapy | 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 |
| |
| TKI-Based Therapy | TKI Therapy ± chemotherapy / immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite improvement level | Proportion of subjects with an improvement in appetite based on A/CS-12 after 12 weeks of treatment | From baseline to Week 12 (end of treatment period) |
| Weight improvement level | Proportion of subjects who did not lose weight relative to baseline after 12 weeks of treatment | From baseline to Week 12 (end of treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | defined as the duration from the start treatment to progression, or patient death | From the date of randomization until the first documented disease progression or death from any cause, whichever occurs first,assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced or metastatic digestive system tumors
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Du | Contact | 024-28851942 | dc1115010@sina.com | |
| Zhenguang Du | Contact | 17702485727 | d1398@lnph.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng Du | The General Hospital of Northern Theater Command | Principal Investigator |
| Zhenguang Du | Organizational Affiliation: Liaoning Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Recruiting | Shenyang | Liaoning | 110016 | China | |
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| TKI-Based Therapy | Drug | TKI-Based Therapy |
|
| Liaoning Cancer Hospital |
| Recruiting |
| Shenyang |
| Liaoning |
| 110042 |
| China |
| ID | Term |
|---|---|
| D002100 | Cachexia |
| D004067 | Digestive System Neoplasms |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
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