Gastric Cancer (GC)Phase 2NCT07913165
A Study of Trifluridine/Tipiracil (TAS-102) Combined With Nedaplatin for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Refractory to ≥ Second-Line Chemotherapy
A Phase 2 study testing TAS102+Nedaplatin in people with Gastric Cancer (GC), run by Tao Zhang.
Trial summary
This study aims to evaluate the efficacy and safety of TAS-102 combined with nedaplatin in patients with advanced gastric or gastroesophageal junction adenocarcinoma who have experienced disease progression after two or more lines of prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC)
- What is being tested?
- TAS102+Nedaplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2028
- Phase
- Phase 2
- 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
- Age: 18-75 years;
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Diagnosis: Histologically or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;
- Prior Treatment: Disease progression or failure after receiving second-line or later chemotherapy;
- TNM Stage: TNM Stage IV (TanyNanyM1);
- Measurable Disease: Presence of at least one radiologically evaluable lesion per RECIST v1.1 criteria (or other applicable criteria) within 21 days prior to enrollment;
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- Adequate Organ Function: Defined as follows within specified timeframes before enrollment;
- Hematology:
- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count (PLT) ≥ 90 × 10⁹/L
- Hemoglobin (Hb) ≥ 90 g/L
- Biochemistry:
- Total Bilirubin (TBIL) ≤ Upper Limit of Normal (ULN)
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 1.5 × ULN
- Alkaline Phosphatase (ALP) ≤ 2.5 × ULN
- Blood Urea Nitrogen (BUN) and Serum Creatinine (Cr) ≤ 1.5 × ULN
- Creatinine Clearance (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
- Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN
- Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
- Cardiac Function:
- Left Ventricular Ejection Fraction (LVEF) ≥ 55% as measured by Echocardiography (ECHO) or Multigated Acquisition Scan (MUGA)
- Corrected QT interval using Fridericia's formula (QTcF) < 470 ms for females and < 450 ms for males on Electrocardiogram (ECG);
- Informed Consent: Voluntarily provide written informed consent prior to any study-specific procedures.
Who cannot join
- Prior TAS-102: Previous treatment with TAS-102;
- Concurrent Anticancer Therapy: Concurrent participation in another clinical trial involving anticancer therapy;
- Recent Major Surgery: Undergone major surgical procedures within 4 weeks prior to enrollment, or has not fully recovered from such procedures;
- Significant Cardiac Disease: History or presence of clinically significant cardiac disease, including but not limited to:
- History of congestive heart failure (CHF) or systolic dysfunction (LVEF < 50%).
- High-risk uncontrolled arrhythmias, significant ventricular arrhythmia (e.g., ventricular tachycardia), or high-grade atrioventricular block.
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- Angina pectoris requiring anti-anginal medication.
- Clinically significant valvular heart disease.
- ECG evidence of transmural myocardial infarction.
- Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
- General Exclusion: Any other condition that, in the judgment of the Investigator, would make the subject unsuitable for participation in the study or compromise protocol compliance.
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
Official title: An Open-Label, Single-Arm, Single-Center Study of Trifluridine/Tipiracil (TAS-102) Combined With Nedaplatin for Patients With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Refractory to ≥2 Prior Lines of Chemotherapy
This study aims to evaluate the efficacy and safety of TAS-102 combined with nedaplatin in patients with advanced gastric or gastroesophageal junction adenocarcinoma who have experienced disease progression after two or more lines of prior chemotherapy.
- Conditions
- Gastric Cancer (GC)
- Being tested
- TAS102+Nedaplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS102+NedaplatinDrug
TAS-102：35mg/m2（BID, D1-5, D8-12）Q4W, 6 cycles + Nedaplatin：80-100mg/m2 Q4W, 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 plus nedaplatin | Experimental | Not described Receives: Drug: TAS102+Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Secondary outcomes (4)
Objective response rate (ORR)
The efficacy of solid tumors was evaluated according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1).
Measured: Through out the study (up to 2 years)
Disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Overall survival (OS)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Measured: Through out the study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913165
- Sponsor's protocol ID
- TAS-102-GAS
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Single-Center Study of Trifluridine/Tipiracil (TAS-102) Combined With Nedaplatin for Patients With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Refractory to ≥2 Prior Lines of Chemotherapy
- ClinicalTrials.gov ID
- NCT07913165
- Acronym / sponsor ID
- TAS-102-GAS
- Conditions
- Gastric Cancer (GC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Nov 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.
This study aims to evaluate the efficacy and safety of TAS-102 combined with nedaplatin in patients with advanced gastric or gastroesophageal junction adenocarcinoma who have experienced disease progression after two or more lines of prior chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 plus nedaplatin | Experimental | Drug: TAS102+Nedaplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age: 18-75 years;
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Diagnosis: Histologically or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;
- Prior Treatment: Disease progression or failure after receiving second-line or later chemotherapy;
- TNM Stage: TNM Stage IV (TanyNanyM1);
Key exclusion criteria (11 listed)
- Prior TAS-102: Previous treatment with TAS-102;
- Concurrent Anticancer Therapy: Concurrent participation in another clinical trial involving anticancer therapy;
- Recent Major Surgery: Undergone major surgical procedures within 4 weeks prior to enrollment, or has not fully recovered from such procedures;
- Significant Cardiac Disease: History or presence of clinically significant cardiac disease, including but not limited to:
- General Exclusion: Any other condition that, in the judgment of the Investigator, would make the subject unsuitable for participation in the study or compromise protocol compliance.
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 |
|---|---|---|
| TAS102+NedaplatinTAS-102：35mg/m2（BID, D1-5, D8-12）Q4W, 6 cycles + Nedaplatin：80-100mg/m2 Q4W, 6 cycles | Drug | TAS-102 plus nedaplatin |
Primary outcome
Progression-free survival (PFS)
Time frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
4 secondary outcomes
Objective response rate (ORR)
Time frame: Through out the study (up to 2 years)
Disease control rate (DCR)
Time frame: Through out the study (up to 2 years)
Overall survival (OS)
Time frame: Through out the study (up to 2 years)
Adverse Event (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Time frame: Through out the study (up to 2 years)
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing TAS102+Nedaplatin in people with Gastric Cancer (GC), run by Tao Zhang.
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 24 inclusion and 11 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 3 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhenyu Lin (027-85871982, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Through out the study (up to 2 years)). 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 3 Nov 2026.