TAIC FOLFOX for Locally Advanced G/GEJA
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
TAIC
Procedure/SurgeryThe 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)
DrugPatients 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.
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: the TAIC groupExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
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
1
DCR
According to RECIST1.1, DCR (disease control rate) was defined as the sum of complete remission, partial response, and stable disease.
Time frame
The DCR is assessed at 4 and 8 weeks by the local investigator.2
ORR
Time frame
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
1
The patients' dysphagia degree
The patients' dysphagia degree was evaluated based on the Stooler Dysphagia Grading Scale . The Stooler Dysphagia Grading Scale (often referred to as the Stooler Classification) is a clinical assessment tool primarily used to evaluate the severity of dysphagia (swallowing difficulties), particularly in patients with esophageal cancer or other conditions causing progressive obstruction. It categorizes swallowing ability into five distinct levels based on the type of food the patient can tolerate. Grade 0 Normal Swallowing. Grade 1 Mild Dysphagia. Grade 2 Moderate Dysphagia. Grade 3 Severe Dysphagia. Grade 4 Complete Obstruction.
Time frame
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.2
The general condition of the patients
The Eastern Cooperative Oncology Group (ECOG) performance status. ECOG 0-1: Patients generally have good functional status. ECOG 2: Patients have compromised functional status. ECOG ≥3: Patients are generally considered unfit for aggressive cytotoxic chemotherapy due to poor tolerance and increased risk of severe adverse events.
Time frame
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.3
OS
Overall Survival (OS) was used as the outcome measure.
Time frame
From enrollment until the date of death from any cause, assessed up to 100 months4
Pathological response
Pathological response was assessed using surgical specimens according to the Becker's tumor regression grade system
Time frame
Surgical resectability assessment should be performed within 2 weeks after the completion of the entire treatment cycle, and pathological response should be conducted if surgery is performed.Sponsors and contacts
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Source ClinicalTrials.gov