Advanced Gastric CancerNCT07371871
A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer
A study testing Trifluridine/Tipiracil (TAS-102) combined with Apatinib in people with Advanced Gastric Cancer, run by Anhui Provincial Cancer Hospital.
Trial summary
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Trifluridine/Tipiracil (TAS-102) combined with Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric cancer confirmed by histopathological or cytological diagnosis;
- unresectable locally advanced or recurrent/metastatic gastric cancer;
- age 18-75 years, regardless of gender;
- ECOG score 0-2;
- previously received second-line treatment for advanced gastric cancer with disease progression during or after treatment;
- at least one measurable lesion present according to RECIST 1.1 criteria;
- laboratory tests meeting the following requirements: (1) Blood routine: HGB≥70g/L; WBC≥4.0×10^9/L; NEUT≥1.5×10^9/L; PLT≥90×10^9/L; (2) Blood biochemistry: ALT, AST≤2.5×upper limit of normal (ULN), serum creatinine≤1.5×upper limit of normal;
- negative pregnancy test for patients of childbearing potential and voluntary use of effective and reliable contraception during the trial.
Who cannot join
- Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment;
- Any of the following conditions that may interfere with oral medication: inability to swallow, chronic diarrhea, or intestinal obstruction;
- Concurrent receipt of any other systemic anti-tumor therapy (excluding local treatment);
- Previous treatment with VEGFR inhibitors (excluding ramucirumab; pan-targeted TKIs are excluded);
- Known history of allergy to any component of the study drugs;
- Subjects with active infectious diseases;
- Patients deemed unsuitable for enrollment by the investigator due to potential increased study-related risks or possible interference with interpretation of study results, as assessed by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer
- Conditions
- Advanced Gastric Cancer
- Being tested
- Trifluridine/Tipiracil (TAS-102) combined with Apatinib
- Keywords
- Advanced Gastric Cancer, TAS-102, Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/Tipiracil (TAS-102) combined with ApatinibDrug
TAS-102: 35 mg/m2/dose, taken orally within 1 hour after breakfast and dinner, twice daily, on days 1-5 of each cycle, followed by a 9-day drug-free interval, with 28 days constituting one cycle.
Apatinib: 500 mg/dose, once daily, administered continuously for 5 days followed by a 2-day break, with 28 days as one cycle. Imaging evaluation should be performed every 2-3 cycles until disease progression or intolerance occurs.
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | Not described Receives: Drug: Trifluridine/Tipiracil (TAS-102) combined with Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate，ORR
Measured: Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).
Secondary outcomes (2)
Duration of Response，DOR
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Progression-Free Survival，PFS
Measured: From date of first dose administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start8 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xiaojing, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371871
- Sponsor's protocol ID
- 2025-LLYJ-0022
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Exploratory Study of Trifluridine/Tipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT07371871
- Acronym / sponsor ID
- 2025-LLYJ-0022
- Conditions
- Advanced Gastric Cancer
- Keywords
- Advanced Gastric Cancer, TAS-102, Apatinib
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 8 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of trifluridine/tipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Drug: Trifluridine/Tipiracil (TAS-102) combined with Apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Gastric cancer confirmed by histopathological or cytological diagnosis;
- unresectable locally advanced or recurrent/metastatic gastric cancer;
- age 18-75 years, regardless of gender;
- ECOG score 0-2;
- previously received second-line treatment for advanced gastric cancer with disease progression during or after treatment;
Key exclusion criteria (7 listed)
- Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment;
- Any of the following conditions that may interfere with oral medication: inability to swallow, chronic diarrhea, or intestinal obstruction;
- Concurrent receipt of any other systemic anti-tumor therapy (excluding local treatment);
- Previous treatment with VEGFR inhibitors (excluding ramucirumab; pan-targeted TKIs are excluded);
- Known history of allergy to any component of the study drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifluridine/Tipiracil (TAS-102) combined with ApatinibTAS-102: 35 mg/m2/dose, taken orally within 1 hour after breakfast and dinner, twice daily, on days 1-5 of each cycle, followed by a 9-day drug-free interval, with 28 days constituting one cycle. Apatinib: 500 mg/dose, once daily, administered continuously for 5 days followed by a 2-day break, with 28 days as one cycle. Imaging evaluation should be performed every 2-3 cycles until disease progression or intolerance occurs. | Drug | research group |
Primary outcome
Objective Response Rate，ORR
Time frame: Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).
2 secondary outcomes
Duration of Response，DOR
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Progression-Free Survival，PFS
Time frame: From date of first dose administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Trifluridine/Tipiracil (TAS-102) combined with Apatinib in people with Advanced Gastric Cancer, run by Anhui Provincial Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Fu He (+86 13053069237, michaelhww@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate，ORR (time frame: Perform imaging evaluation At the end of Cycle 2 or Cycle3 (each cycle is 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.