ClinicalTrials.gg
Not yet recruitingNCT07913165Updated Nov 3, 2026

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 interventional study of TAS102+Nedaplatin in Gastric Cancer (GC), sponsored by Tao Zhang. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Tao Zhang · Phase 2, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer (GC)

Browse trials for

03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 36 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Tao Zhang is the lead sponsor of 17 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18-75 years;
  2. Performance Status: (ECOG) performance status score of 0 or 1;
  3. Diagnosis: or pathologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction;
  4. Prior Treatment: Disease progression or failure after receiving or later chemotherapy;
  5. TNM Stage: TNM Stage IV (TanyNanyM1);
  6. : Presence of at least one radiologically evaluable lesion per v1.1 criteria (or other applicable criteria) within 21 days prior to enrollment;
  7. Adequate Organ Function: Defined as follows within specified timeframes before enrollment;

    • Hematology:

      • (ANC) ≥ 1.5 × 10⁹/L
      • count (PLT) ≥ 90 × 10⁹/L
      • (Hb) ≥ 90 g/L
    • Biochemistry:

      • Total (TBIL) ≤ (ULN)
      • (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
      • (CrCl) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
    • Coagulation:

      • (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN
      • Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN
    • Cardiac Function:

      • (LVEF) ≥ 55% as measured by Echocardiography (ECHO) or Multigated Acquisition Scan (MUGA)
      • interval using Fridericia's formula (QTcF) \< 470 ms for females and \< 450 ms for males on (ECG);
  8. : Voluntarily provide written informed consent prior to any study-specific procedures.

Exclusion criteria

Exclusion Criteria:

  1. Prior TAS-102: Previous treatment with TAS-102;
  2. Concurrent Anticancer Therapy: Concurrent participation in another clinical trial involving anticancer therapy;
  3. Recent Major Surgery: Undergone major surgical procedures within 4 weeks prior to enrollment, or has not fully recovered from such procedures;
  4. Significant Cardiac Disease: History or presence of cardiac disease, including but not limited to:

    • History of congestive heart failure (CHF) or systolic dysfunction ( \< 50%).
    • High-risk uncontrolled arrhythmias, significant ventricular arrhythmia (e.g., ventricular tachycardia), or high-grade atrioventricular block.
    • Angina pectoris requiring anti-anginal medication.
    • Clinically significant valvular heart disease.
    • evidence of transmural myocardial infarction.
    • Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
  5. 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.
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    TAS-102 plus nedaplatin

    Drug: TAS102+Nedaplatin

Interventions

  • DrugTAS102+Nedaplatin

    TAS-102:35mg/m2(BID, D1-5, D8-12)Q4W, 6 cycles + Nedaplatin:80-100mg/m2 Q4W, 6 cycles

06

What researchers measure

Primary outcomes

  1. Progression-free survival (PFS)

    The efficacy of solid tumors was evaluated according to RECIST v1.1

    Time frame: Through out the study (up to 2 years)

Secondary outcomes

  1. 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).

    Time frame: Through out the study (up to 2 years)

  2. Disease control rate (DCR)

    The efficacy of solid tumors was evaluated according to RECIST v1.1

    Time frame: Through out the study (up to 2 years)

  3. Overall survival (OS)

    The efficacy of solid tumors was evaluated according to RECIST v1.1

    Time frame: Through out the study (up to 2 years)

  4. 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).

    Time frame: Through out the study (up to 2 years)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 293 non-industry phase 2 interventional studies under Stomach Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 76. This study's planned 12 months is below that.

Counting every sponsor, half of 358 studies reached it within 50 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2025
First posted
Nov 3, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07913165
Lead sponsor
Tao Zhang
Responsible party
Tao Zhang (MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Sponsor-investigator
First posted
Nov 3, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Zhenyu Lin
Contact
whxhlzy@hust.edu.cn
027-85871982

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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