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A single-arm, prospective Clinical Study of apatinib combined with SOX protocol for first-line treatment of advanced gastric cancer

A single-arm, prospective Clinical Study of apatinib combined with SOX protocol for first-line treatment of advanced gastric cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017837
Enrollment
Unknown
Registered
2018-08-17
Start date
2018-08-30
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

not operable, recurrent or metastatic advanced gastric or gastric esophageal junction adenocarcinoma

Interventions

Sponsors

Gansu Province Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~75 years; 2. ECOG PS 0-2; 3. Advanced gastric cancer or gastric esophageal junction adenocarcinoma confirmed by pathological histology and/or cytology(Unable to surgery III-IV period);(patients who recurred of clinical treatment 5 years later.); 4. Have not received chemotherapy or other targeted therapy in the past; 5. Estimated survival time=3 mouths; 6. If the main organs function normally, and meet the following standards: (1) the standard of blood routine examination should meet :(no blood transfusion and blood products within 14 days) WBC > 4.0 x 10^9/L; ANC =1.5 x 10^9/L; PLT = 80 x 10^9/L; HGB =80 g/L; (2) biochemical examination shall meet the following standards: TBIL 50 ml/min (Cockcroft - Gault); 7. Surgery was performed more than 4 weeks ago and the wound was completely healed; 8. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib. For male, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 weeks after the last given Apatinib; 9. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Accompanied by serious heart, liver and kidney diseases;Neurological and mental diseases;severe infection; 2. Clear tendency to gastrointestinal bleeding such as:bleeding ulcers,fecal occult blood (++);A history of black stool and hematemesis within 2 months; Abnormal blood coagulation function (INR>1.5 x ULN, APTT>1.5 x ULN); 3. Hypertension and failure to be reduced to normal range by antihypertensive drugs( Systolic pressure>140mmHg, Diastolic pressure >90mmHg); Unstable angina pectoris; Newly diagnosed with angina pectoris within 3 months before screening or with myocardial infarction within 6 months before screening; Cardiac arrhythmia (including QTcF: 450 ms for men and 470 ms for women) requires long-term use of anti-arrhythmia drugs and grade II cardiac insufficiency according to the New York heart association; 4. Have significant impacts on oral absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 5. Women who are pregnant or lactating; Persons with fertility who are unwilling or unable to take effective contraceptive measures; 6. Participated in other clinical trials of anti-tumor drugs within 4 weeks; 7. Have received any radiotherapy, chemotherapy and targeted treatment before; 8. The researchers consider those who were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Progression Free Surivical;

Secondary

MeasureTime frame
Overall Surivival;Disease Control Rate;Objective Remission Rate;QoL;

Countries

China

Contacts

Public ContactYang Yan

Gansu Province Cancer Hospital

13639395521@163.com+86 13639395521

Outcome results

None listed

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