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An ambispective cohort study for apatinib versus S-1 maintenance treatment after first-line chemotherapy in advanced gastric cancer

An ambispective cohort study for apatinib versus S-1 maintenance therapy after first-line chemotherapy in patients with metastatic or recurrent gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019382
Enrollment
Unknown
Registered
2018-11-08
Start date
2017-11-04
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Advanced gastric cancer

Interventions

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old, male and female; 2. Advanced gastric or gastroesophageal junctional adenocarcinoma confirmed by pathology or histology with measurable lesions and assessed as CR, PR, or SD after 6-8 cycles of first-line chemotherapy; 3. The bone marrow and liver and kidney function were normal; 4. ECOG PS 0-1; 5. The survival period is expected to be longer than or equal to 3 months. The patient has treatment indication, and no chemotherapy absolute contraindicatihon; 6. Patients can understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who have been allergic to the drugs and/or their excipients required for the study; 2. Urine protein detection 2+ or above, or 24-hour urinary protein quantification >1.0g; 3. Gastrointestinal bleeding or researchers believe that the gastrointestinal bleeding may occur; 4. Patients with Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 5. Patients with central nervous system metastasis; 6. According to the researcher's judgment, there are other serious risks to the patient's safety or the accompanying diseases that affect the patient's completion of the study; 7. Pregnant or lactating women; 8. Except for patients with contraindications to apatinib; 9. Patients considered by the doctor to be unfit for inclusion.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;ORR;DCR;Safety;QoL;

Countries

China

Contacts

Public ContactShu Zhang

Shandong Cancer Hospital

zhangshu@csco.org.cn+86 0531-67626836

Outcome results

None listed

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