Gastric Cancer (Diagnosis)Phase 2TFLAGNCT07655024
TAIC FOLFOX for Locally Advanced G/GEJA
A Phase 2 study testing TAIC and FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) in people with Gastric Cancer (Diagnosis) and Gastroesophageal Junction Adenocarcinoma, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Gastric cancer is the fifth most common malignancy worldwide in terms of both incidence and mortality. The majority of cases are diagnosed at advanced stage-often presenting with severe complications such as malignant stricture, obstruction, bleeding, and cancer-related malnutrition-which impinge on quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer (Diagnosis), Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- TAIC and FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Dec 2028
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Pathologically diagnosed with G/GEJA
- Confirmed by the surgeon as initially unresectable advanced G/GEJC
- Contraindicated to surgery due to frailty or comorbidities
- Expected survival period ≥ 3 months
Who cannot join
- Primary malignant tumors
- Gastrointestinal obstruction caused by lesions in the distal stomach, duodenum, pancreas or other organs
- Acute infection, severe liver or kidney dysfunction or coagulation disorder
- Allergic to the drugs or with mental disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Quanda Liu, PhD contact
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange St, West-city District, Beijing, China
Beijing
Yan Sun, PhD, +86 15010797262, 6327391616@qq.com
About this study
Official title: FOLFOX-Based Transarterial Infusion Chemotherapy for Locally Advanced Gastric Cancer and Gastroesophageal Junction Adenocarcinoma: Protocol of an Open-Label, Multicentre, Single-arm, Phase Ⅱ Trial
Gastric cancer is the fifth most common malignancy worldwide in terms of both incidence and mortality. The majority of cases are diagnosed at advanced stage-often presenting with severe complications such as malignant stricture, obstruction, bleeding, and cancer-related malnutrition-which impinge on quality of life and survival outcomes. For patients with unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (G/GEJA), first-line systemic therapy remains predominantly platinum- and fluoropyrimidine-based combination chemotherapy, and targeted agents or immunotherapy can be added based on the expression of biomarkers. Under this standard approach, the median overall survival (mOS) for localized unresectable G/GEJA is approximately 14-20 months. For metastatic G/GEJA, the prognosis remains poor with an mOS of less than 1 year, despite the proven efficacy of chemotherapeutic agents. Moreover, up to 25% of cancer survivors report a significant decline in quality of life due to gastrointestinal symptoms during, soon after, or many years after treatment.
Interventional oncology approaches-including trans-arterial infusion chemotherapy (TAIC), embolization (TAE), and chemoembolization (TACE)-represent promising locoregional therapeutic strategies. TAIC allows for the direct delivery of cytotoxic agents into the tumor-feeding arteries, thereby maximizing intra-tumoral drug concentration. As one of the most well-recognized applications, hepatic arterial infusion chemotherapy (HAIC) has been demonstrated in liver cancer by elevating local drug exposure, markedly enhancing antitumor efficacy while minimizing systemic adverse effects. Moreover, chemotherapeutic agents may exert secondary systemic activity against clinically or subclinically disseminated metastases upon systemic circulation, contributing to a sustained "secondary chemotherapy" effect. Owing to its favorable safety profile and preserved antitumor activity, TAIC is particularly suited for frail or elderly patients who are ineligible for surgery or conventional systemic chemotherapy.
Given the persistent limitations of current therapeutic paradigms, the feasibility and safety of trans-arterial therapy in the treatment of anti-tumor, hemostasis and obstruction relief for locally advanced G/GEJC remains urgent. The present study aimed to assess the efficacy and safety of TAIC for locally advanced G/GEJA.
- Being tested
- TAIC, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Keywords
- Unresectable Gastric cancer, Esophagogastric junction adenocarcinoma, Transarterial infusion chemotherapy
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAICProcedure or surgery
The Seldinger method was used to insert a vascular sheath through the unilateral femoral artery. A 5 F angiographic catheter (C2, RLG, or RH TYPE, Cook Corporation, Bloomington, IN, USA) was inserted into left gastric, short gastric, and esophageal proper arteries under fluoroscopy guidance, and the condition of each branch vessel was visualized by catheter angiography. Then a 2.7 F microcatheter was introduced into the artery that delivered blood supply to the tumor using the coaxial catheter technology. TAIC were performed based on the blood supply and staining degree of the tumor. For the target vessel, by selective catheterization and DSA (Digital Subtraction Angiography), the vascular distribution and staining degree of the tumor can be directly observed.
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)Drug
Patients in the TAIC group will undergo FOLFOX-based TAIC at weeks 0 and 4 and receive FOLFOX-based IVC at weeks 2 and 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) administered as a 2-hour transarterial infusion, leucovorin (400 mg/m²) administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour transarterial infusion. According to the results of the genetic mutation status, HER2-positive patients are administered trastuzumab in combination every cycle.
| Study group | Role | What they receive |
|---|---|---|
| the TAIC group | Experimental | Patients in the TAIC group will undergo FOLFOX-based TAIC at weeks 0 and 4 and receive FOLFOX-based IVC at weeks 2 and 6. The FOLFOX-based TAIC consists of oxaliplatin (85 mg/m²) administered as a 2-hour transarterial infusion, leucovorin (400 mg/m²) administered as a 2-hour transarterial infusion, and fluorouracil (2400 mg/m²) administered as a 44-hour transarterial infusion. According to the results of the genetic mutation status, HER2-positive patients are administered trastuzumab in combination every cycle. Receives: Procedure: TAIC; Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life
The quality of life was assessed using the EORTC QLQ-C30. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status /QoL represents a high QoL, but a high score for a symptom scale /item represents a high level of symptomatology / problems.
Measured: From enrollment to the end of treatment at 10 weeks, 3 days before each administration period and within 2 weeks after the end of the treatment.
Secondary outcomes (2)
DCR
According to RECIST1.1, DCR (disease control rate) was defined as the sum of complete remission, partial response, and stable disease.
Measured: The DCR is assessed at 4 and 8 weeks by the local investigator.
ORR
Measured: ORR is defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.The ORR is assessed at 4 and 8 weeks by the local investigator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Nov 2025
- Primary completion1 Jan 2028 (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 (Diagnosis)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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanda Liu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Quanda Liu, PhD, Study director, Guanganmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655024
- Sponsor's protocol ID
- 2025-276-KY
- Acronym
- TFLAG
- Status last verified
- Apr 2026
- First submitted
- 8 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators agree to allow the auditors/inspectors/monitors to have direct access to the trial records for review. The investigator will make every effort to help with the performance of the audits and inspections, giving access to all necessary facilities, data, and documents.