Neoadjuvant TACiE in Locally Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Prospective, Phase 2, Single Arm Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05346874
• Other study ID #: ZSGC-TACiE02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Zhaoqing Tang
• Phone: +8613817125778
• Email: tang.zhaoqing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction.

The TACiE protocol includes four cycles. Transcatheter oxaliplatin and concurrent embolism on day 1 and oral S-1 on day 1-14 will be administrated in the first and third cycles. Intra-venous oxaliplatin on day 1 and oral S-1 on day 1-14 (SOX) will be administrated in the second and fourth cycles.

Description:

The treatment of advanced gastric cancer has been a significant global health problem. With surgery still the backbone, many clinical trials have shown the benefit of perioperative treatment to gastric cancer patients. The neoadjuvant treatment is one of the most important parts.

Besides chemotherapy and chemoradiotherapy, the report of transcatheter arterial infusion (TAI) or transcatheter arterial embolism (TAE) in gastric cancer is relatively limited, though some case reports have showed its efficacy and safety in advanced gastric cancer. The combination of TAI and TAE (TACiE) may be more perspective in the treatment of gastric cancer. With transarterial infusion chemotherapy, TACiE increases the local concentration of chemotherapeutic agents and reduces adverse reaction. With embolization, TACiE blocks the blood supply and causes the necrosis of tumors, in this way exposing tumor antigen and promoting tumor immunity.

Based on those knowledges, we designed this prospective, single-center, single-arm, phase 2 trial to evaluate the feasibility and safety of neoadjuvant transcatheter infusion and embolism (TACiE) in patients with locally advanced adenocarcinoma of stomach and gastroesophageal junction. The primary purpose of this study is to evaluate the pathologic complete response (pCR) rate of TACiE. The second purpose is to evaluate pathologic response rate (pRR), objective Response Rate (ORR), overall survival (OS) and progression-free survival (PFS) of the patients enrolled in this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: May 1, 2025
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18 to 75 years old;

• The Karnofsky Performance Scale (KPS) score >=80;

• Adenocarcinoma of stomach and gastroesophageal junction (Siewert II/III) diagnosed pathologically;

• clinical T3-4a/N+/M0 (The 8th edition of the American Joint Committee on Cancer (AJCC) staging system);

• According to the Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 standard, there is at least one evaluable lesion in the abdominal CT/MRI;

• The surgeons participating in this study judged the lesion to be resectable;

• Physical condition allows the surgery;

Exclusion Criteria:

• Distant metastasis or local unresectable factors;

• Cytotoxic chemotherapy, radiotherapy, immunotherapy or radical surgery for the treatment of this gastric cancer, except for corticosteroids;

• Active autoimmune diseases or a history of autoimmune diseases;

• History of malignant tumors within 2 years;

• Gastrointestinal bleeding within two weeks prior to enrollment, or those with high bleeding risk;

• Gastrointestinal perforation and/or fistula occurred within 6 months before enrollment;

• Upper gastrointestinal obstruction or abnormal physiological function or suffering from malabsorption syndrome, which may affect the absorption of drugs;

• Weight loss >=20% within 2 months before enrollment;

• A history of the following lung diseases: interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, etc.;

• Uncontrollable systemic diseases including diabetes, hypertension, etc.; Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis, HIV infection, etc.;

• Untreated patients with chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or hepatitis C virus (HCV) RNA positive patients should be excluded;

• Any of the following cardiovascular risk factors (refer to Research Guide);

• Known peripheral nerve disease >=NCI CTCAE Grade 1. However, patients with only the disappearance of the deep tendon reflex (DTR) need not be excluded;

• Moderate or severe renal damage [creatinine clearance equal to or lower than 50 ml/min (calculated according to the Cockcroft and Gault equation)], or serum creatinine> upper limit of normal (ULN); People with known dihydropyrimidine dehydrogenase (DPD) deficiency;

• Those who are allergic to any research drug ingredients;

• Underwent major surgery within 28 days prior to enrollment;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
The first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1. The second and fourth cycles: intra-venous oxaliplatin 135mg/m2, day 1.
• Teysuno
Oral S-1, 40mg-60mg, day 1-14 for four 21-day cycles.

Procedure:
• Transarterial chemoembolization (TACE)
In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1.

Locations

Country	Name	City	State
China	ZhongShan hospital FuDan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

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van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR) rate	The percentage of patients found no tumor residual in primary tumor and resected lymph nodes.	two weeks after surgery
Secondary	Pathological response rate (pRR)	The percentage of patients found less than 10% tumor residual in primary tumor.	two weeks after surgery
Secondary	Objective response rate (ORR)	The percentage of patients found complete response or partial response to preoperative therapy according to RECIST v1.1.	up to 3 months
Secondary	The incidence of treatment emergent adverse events.	Safety	up to 1 month after surgery.
Secondary	Overall survival	The time from enrollment to death caused by any causes or censor.	From date of enrollment until the date of death from any cause, assessed up to 36 months
Secondary	Progressive free survival	The time from enrollment to tumor progression, death or censor.	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months