NCT03822130

Brief Summary

This project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 20, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

January 23, 2019

Last Update Submit

February 18, 2019

Conditions

Successful Conversion Rate of OperationUnresectable Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Successful conversion rate of operation

    42 days

Secondary Outcomes (2)

  • ORR

    42 days

  • PFS

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (3)

Group 1

PLACEBO COMPARATOR

Systemic Chemotherapy + Oral Chemotherapy Group

Drug: Systemic ChemotherapyDrug: Oral Chemotherapy

Group 2

EXPERIMENTAL

Arterial catheter infusion chemotherapy plus oral chemotherapy group

Drug: Arterial catheter infusion chemotherapyDrug: Oral Chemotherapy

Group 3

EXPERIMENTAL

Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group

Drug: Arterial catheter infusion chemotherapyDrug: Sodium BicarbonateDrug: Oral Chemotherapy

Interventions

Arterial catheter infusion chemotherapyDRUG

Arterial catheter infusion chemotherapy

Group 2Group 3
Sodium BicarbonateDRUG

Arterial catheter infusion Sodium Bicarbonate

Group 3
Systemic ChemotherapyDRUG

Systemic Chemotherapy

Group 1
Oral ChemotherapyDRUG

Oral Chemotherapy

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 75 years;
  • Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
  • Pathological diagnosis of gastric cancer;
  • No contraindication of chemotherapy;
  • Patients who did not undergo chemotherapy or were diagnosed for the first time.

You may not qualify if:

  • Those who fail to comply with the requirements of the trial, obviously violate this regimen, or change to other regimens in the course of treatment;
  • The life expectancy of patients with extensive systemic metastasis is less than 3 months;
  • Leukocyte count is less than 2\*109/L and platelet count is less than 75\*10\^9/L;
  • Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
  • Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
  • Patients with distant metastasis (excluding group 16 lymph node metastasis);
  • Patients with other tumors, with a history of malignant tumors (excluding early primary cancers);
  • The patient himself asked to withdraw from the trial;
  • Researchers believe that patients are not suitable for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Sodium BicarbonateNeoadjuvant TherapyDrug Therapy

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsCombined Modality TherapyTherapeutics

Central Study Contacts

Ming Chao

CONTACT

+86 13957139239z2doctor_chaoming@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 30, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 20, 2019

Record last verified: 2019-01

Locations

CN(1)