TAIC FOLFOX for Locally Advanced G/GEJA
TFLAG
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
1 other identifier
interventional
31
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
June 17, 2026
April 1, 2026
2.2 years
May 8, 2026
June 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
The DCR is assessed at 4 and 8 weeks by the local investigator.
ORR
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.
Other Outcomes (8)
The patients' dysphagia degree
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.
The general condition of the patients
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.
OS
From enrollment until the date of death from any cause, assessed up to 100 months
- +5 more other outcomes
Study Arms (1)
the TAIC group
EXPERIMENTALPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Surgery, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange St, West-city District, Beijing, China
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Quanda Liu, PhD
Guanganmen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 8, 2026
First Posted
June 17, 2026
Study Start
November 1, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
June 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.