NCT07655024 TAIC FOLFOX for Locally Advanced G/GEJA
| NCT ID | NCT07655024 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Condition | Gastric Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 31 participants in total. It began in 2025-11-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Quanda Liu, PhD
STUDY DIRECTOR
Guanganmen Hospital
Frequently Asked Questions
Who can join the NCT07655024 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07655024 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07655024 currently recruiting?
Yes, NCT07655024 is actively recruiting participants. Contact the research team at 632739616@qq.com for enrollment information.
Where is the NCT07655024 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07655024 clinical trial?
NCT07655024 is sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. The principal investigator is Quanda Liu, PhD at Guanganmen Hospital. The trial plans to enroll 31 participants.
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