Neoadjuvant TACiE in Locally Advanced Gastric Cancer

NCT05346874 | Unknown Phase 2

• 1 other identifier: ZSGC-TACiE02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

neoadjuvant therapy; transcatheter arterial infusion; transcatheter arterial embolism; SOX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pathological response rate (pRR)

  two weeks after surgery

• Objective response rate (ORR)

  up to 3 months

• The incidence of treatment emergent adverse events.

  up to 1 month after surgery.

• Overall survival

  From date of enrollment until the date of death from any cause, assessed up to 36 months

• Progressive free survival

  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

Study Arms (1)

SOX-TACiE

EXPERIMENTAL

Preoperative transcatheter arterial chemoinfusion and embolism alternated with intra-venus chemotherapy.

Drug: Oxaliplatin; Drug: Teysuno; Procedure: Transarterial chemoembolization (TACE)

Interventions

Oxaliplatin DRUG

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.

SOX-TACiE

Teysuno DRUG

Oral S-1, 40mg-60mg, day 1-14 for four 21-day cycles.

SOX-TACiE

Transarterial chemoembolization (TACE) PROCEDURE

In the first and third cycles : transcatheter arterial infusion of oxaliplatin 85mg/m2, day 1; transcatheter arterial embolism of tumor feeding arteries, day 1.

SOX-TACiE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (13)

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; tegafur-gimeracil-oteracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Zhaoqing Tang

CONTACT

+8613817125778; tang.zhaoqing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 26, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: May 1, 2025
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)