NCT07655024RecruitingPhase 2
TAIC FOLFOX for Locally Advanced G/GEJA
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 8 May 2026
- Start date
- 1 Nov 2025
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07655024
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 31
- From 1 Nov 2025 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Primary malignant tumors
- Acute infection, severe liver or kidney dysfunction or coagulation disorder
- Allergic to the drugs or with mental disorders
Other
- Gastrointestinal obstruction caused by lesions in the distal stomach, duodenum, pancreas or other organs
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General Surgery, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixiange St, West-city District, Beijing, China Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.