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Clinical efficacy and safety of apatinib combined with DOS strategy in the treatment of locally advanced gastric cancer

Clinical efficacy and safety of apatinib combined with DOS strategy in the treatment of locally advanced gastric cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019223
Enrollment
Unknown
Registered
2018-10-31
Start date
2018-11-25
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

gastric cancer

Interventions

Case series:Apatinib+DOS

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with colorectal cancer diagnosed by histopathology or cytology; 2. At least one measurable lesion (satisfying the RECIST 1.1 criteria); patients who have not had distant metastases, have not undergone surgery, chemotherapy, radiation therapy, and other treatments; 3. Male and female aged at least 18 years old; 4. ECOG PS: 0-2 points; 5. The estimated survival period is =3 months; 6. The organ function level meets the following criteria: Blood routine: hemoglobin =90g/L, absolute neutrophil count (ANC) =1.5×10^9/L, platelet =80×10^9/L; blood biochemistry: ALT, AST=2.5 ×ULN, if there is liver metastasis = 5 × ULN, serum total bilirubin = 1.5 × ULN, serum creatinine = 1.5 times × ULN, serum albumin = 30g/L; 7. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception. In the case of men, surgical sterilization should be carried out or appropriate methods of contraception should be agreed to during the trial and 8 weeks after the last administration of the experimental drugs; 8. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. A patient with a distant organ metastasis; 2. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade II or higher coronary heart disease, grade II arrhythmia (including QTc interval prolongation) >470 ms) and grade I cardiac insufficiency; 3. Patients who have previously received tumor-related treatment (surgery, chemotherapy, radiotherapy, Chinese medicine and Chinese medicine); 4. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 5. Patients with a clear tendency to hemorrhage; 6. Combined with pyloric obstruction, upper gastrointestinal bleeding, digestive tract perforation, obstructive jaundice, severe malnutrition and other serious complications; 7. Imaging studies have shown that the tumor has invaded important blood vessels or that the patient's tumor has a high probability of invading important blood vessels during treatment and causing fatal bleeding; 8. Have HIV infection or a patient; 9. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to enrollment; 10. Patients with positive urine protein; 11. Patients with active brain metastases; 12. Patients with other malignancies within 5 years (except for completely cured cervical carcinoma in situ or basal cells or squamous epithelial skin cancer); 13. Pregnant or lactating women; 14. According to the investigator's judgment, those who are seriously at risk to the patient's safety or affect the patient's completion of the study and those who the investigator believes are not suitable for inclusion should not be included.

Design outcomes

Primary

MeasureTime frame
Surgical resection rate;Surgical cure rate;

Secondary

MeasureTime frame
Overall survival;Progression free survival;Disease control rate;Pathological complete response rate;Drug safety;

Countries

China

Contacts

Public ContactWei Zhang

The First Affiliated Hospital of Chongqing Medical University

742676160@qq.com+86 13022309167

Outcome results

None listed

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