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A prospective, one-arm, open study of apatinib mesylate in the treatment of advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma

A prospective, one-arm, open study of apatinib mesylate in the treatment of advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049734
Enrollment
Unknown
Registered
2021-08-08
Start date
2021-08-09
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma

Interventions

Single arm group:medical treatement

Sponsors

Sanmenxia Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old, no gender limit; 2. Patients with advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma confirmed by histology or cytology; 3. There is no serious liver and kidney damage, and the functional level of the organs must meet the following requirements: ANC >= 1.5x10^9/L; PLT >= 90x10^9/L; Hb >= 90 g/L; TBIL = 50 mL/min (Cockcroft-Gault formula); LVEF >= 50%; QT interval (QTcF) corrected by Fridericia method = 3 months; 7. The investigator assesses that the patient can comply with the requirements of the protocol; 8. Sign the informed consent document.

Exclusion criteria

Exclusion criteria: 1. Hypertension patients who have been treated with a variety of antihypertensive drugs but are still difficult to control (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 90 mmHg); 2. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) and a history of coronary angioplasty or stent placement within 6 months before enrollment; 3. Patients with a large amount of pleural effusion or ascites requiring drainage; 4. Patients with partial or complete gastrointestinal obstruction; 5. According to the judgment of the investigator, the abnormal blood coagulation function has clinical significance, has a bleeding tendency or is receiving thrombolysis or anticoagulation therapy; 6. Women who are pregnant or breastfeeding, have fertility but refuse to take contraceptive measures; 7. According to the judgment of the investigator, there are concomitant diseases (diabetes, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study; 8. Patients with unhealed wounds, unhealed ulcers or unhealed fractures; 9. Patients who are allergic to apatinib mesylate tablets and/or its excipients; 10. The investigator judges other situations that are not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall survival;1-year overall survival;2-year overall survival;objective response rate;disease control rate;

Countries

China

Contacts

Public ContactTian Chuntao

Sanmenxia Central Hospital

2387365387@qq.com+86 13623981930

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026