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A single-center, single-arm clinical study of apatinib mesylate combined with SOX in postoperative adjuvant treatment of gastric cancer and gastroesophageal junction adenocarcinoma

A single-center, single-arm clinical study of apatinib mesylate combined with SOX in postoperative adjuvant treatment of gastric cancer and gastroesophageal junction adenocarcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047395
Enrollment
Unknown
Registered
2021-06-16
Start date
2021-06-17
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Gastric cancer

Interventions

Sponsors

Heping Hospital Affiliated to Changzhi Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 to 70 years; 2. D2 lymph node dissection has been performed for gastric cancer and gastroesophageal junction adenocarcinoma, without gross or microscopic residual tumor (i.e. R0 resection); 3. Postoperative pathological stages were III stage gastric cancer and gastroesophageal junction adenocarcinoma; 4. In good general condition, ECOG PS: 0-1 points; 5. Baseline blood routine and biochemical indicators meet the following standards: (1) Hemoglobin >= 9.0 g/dL; (2) Absolute count of neutrophils (ANC) >=1,500/mm^3; (3) platelet count >=100,000/mm^3; (4) Total bilirubin =2+, 24h urine protein quantitative protein must be =3 months; 9. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days prior to enrolment, be negative, and be willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug.For men, surgical sterilization or consent to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug; 10. Subjects volunteered to participate in this study, signed informed consent, and showed good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. People who have been confirmed to be allergic to apatinib, tiggio and oxaliplatin; 2. Patients with hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 3. Multiple factors that may affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); 4. Patients with a definite tendency of gastrointestinal bleeding, including the following conditions: local active ulcer lesions, and fecal occult blood (++) was not included in the group;Patients with a history of melena or hematemesis within 2 months; Gastroendoscopy is required for stool occult blood (+) without surgical resection of the primary lesion of the gastric tumor, such as ulcerative gastric cancer, and the major investigator believes that massive gastrointestinal bleeding may occur; 5. Patients have previously received any targeted therapy; 6. Postoperative pathology showed positive margin; 7. Patients with internal systemic diseases and psychiatric diseases are not suitable for radiotherapy or chemotherapy; 8. Patients with acute infection requiring antibiotic treatment; 9. Patients who have participated in clinical trials of other drugs within four weeks; 10. Patients with concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study; 11. Patients considered unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Disease-free survival at 2 years;

Secondary

MeasureTime frame
2-year recurrence rate;Overall survival;Safety;

Countries

China

Contacts

Public ContactZhao Qiang

Heping Hospital Affiliated to Changzhi Medical College

458597129@qq.com+86 15525112001

Outcome results

None listed

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