FindTrial
Sign In

A study on the efficacy and safety of combining Trifluridine and Tipiracil Hydrochloride Tablets (TAS-102) with apatinib in the treatment of advanced gastric cancer patients who have failed first-line therapy

A study on the efficacy and safety of combining Trifluridine and Tipiracil Hydrochloride Tablets (TAS-102) with apatinib in the treatment of advanced gastric cancer patients who have failed first-line therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105855
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

gastric cancer

Interventions

Test group 1-1:Trifluridine and Tipiracil Hydrochloride Tablets combined with apatinib 250mg po qd
Test group 1-2:Trifluridine and Tipiracil Hydrochloride Tablets combined with apatinib 500mg po qd
Test group 1-3:Trifluridine and Tipiracil Hydrochloride Tablets combined with apatinib 750mg po qd
Test group 2:Trifluridine and Tipiracil Hydrochloride Tablets(TAS-102) combined with apatinib (optimal dose)

Sponsors

Qinghai University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed as adenocarcinoma of the stomach or GEJ; 2. Failed after first-line chemotherapy with fluorouracil-based drugs + platinum + PD-1 inhibitor; 3. Patients aged over 18 years and under 75 years 4. Expected survival period >= 6 months; 5. For advanced patients, imaging assessment: According to the RECIST standard, at least one measurable lesion; 6. No obvious organ dysfunction; 7. The patient's ECOG performance status is 0-2; 8. The patient must have the ability to understand and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combine other tumors; 2. Currently receiving other anti-tumor treatments; 3. Patients with serious coexisting diseases that require active treatment; 4. Pregnant or lactating women; 5. Individuals with alcohol or drug abuse, or psychological, social conditions that may interfere with the assessment of research results; 6. Allergic to any component of the trial drug; 7. With active bleeding, ulcers, intestinal perforation, or intestinal obstruction; 8. Within 30 days after major surgery; 9. With uncontrolled hypertension due to medication.

Design outcomes

Primary

MeasureTime frame
DLTs within 28 days;security;progression free survival;—

Secondary

MeasureTime frame
objective remission rate;Incidence rate of adverse events;living quality (EORTC QLQ-C30) ;overall survival;—

Countries

China

Contacts

Public ContactYushuang Luo

Qinghai University Affiliated Hospital

qfyluoyushuang@163.com+86 138 9720 8152

Outcome results

None listed

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