NCT05774964

Brief Summary

The aim of this study is to explore the therapeutic effect of Quintuple method in the treatment of patients with multiple and refractory liver metastases from colorectal cancer. A randomized single-arm clinical trial was conducted.The intervention group was treated with single SOX chemotherapy, SOX chemotherapy combined with cetuximab targeted therapy, SOX chemotherapy combined with low-dose cetuximab targeted therapy combined with three-drug regimen（Quintuple method）, and the RECIST 1.1 solid tumor evaluation criteria were used to assess the disease.

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2023

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

March 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

March 7, 2023

Last Update Submit

March 7, 2023

Conditions

For Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple Method

Keywords

Quintuple methodColorectal Liver Metastases

Outcome Measures

Primary Outcomes (3)

  • Overall Response Rate (ORR)

    Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1

    Up to approximately 2 years

  • Overall Survival (OS)

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. For subjects who survived or were lost to follow-up by the data analysis cutoff date, survival was truncated by the subject's last known survival time

    Up to approximately 2 years

  • Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.

    Up to approximately 2 years

Study Arms (3)

Chemotherapy alone group

EXPERIMENTAL

Patients treated with chemotherapy using SOX regimen alone. SOX regimen every 3 weeks,oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily.

Drug: OxaliplatinDrug: S1

Chemotherapy targeted group

EXPERIMENTAL

Patients treated with cetuximab targeted therapy in combination with chemotherapy using SOX regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously,once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Drug: OxaliplatinDrug: S1Drug: Cetuximab

Quintuple method group

EXPERIMENTAL

Patients treated with a combination of SOX regimen, cetuximab, and folic acid, vitamin A, and metronidazole three-drug regimen.SOX regimen every 3 weeks, oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area, and tegafur orally on d2-d15 at 20 mg three times daily. Cetuximab combined with chemotherapy was administered simultaneously,once every three weeks, and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area. Metronidazole 0.4g/time, qd;vitamin A 5,000 units/time, qd; folic acid 5 mg/time,qd. The latter three drugs were continued until the end of all chemotherapy cycles.

Drug: OxaliplatinDrug: S1Drug: CetuximabDrug: MetronidazoleDrug: Vitamin ADrug: Folic acid

Interventions

OxaliplatinDRUG

Oxaliplatin via intravenous drip on d1 at a dose of 130 mg/m2 × patient 's body surface area

Chemotherapy alone groupChemotherapy targeted groupQuintuple method group
S1DRUG

Orally on d2-d15 at 20 mg three times daily

Also known as: Tegafur,Gimeracil and Oteracil Porassium Capsules
Chemotherapy alone groupChemotherapy targeted groupQuintuple method group
CetuximabDRUG

Cetuximab combined with chemotherapy was administered simultaneously, once every three weeks,and intravenous drip was performed before oxaliplatin at a dose of 250 mg/m2 × body surface area.

Chemotherapy targeted groupQuintuple method group
MetronidazoleDRUG

Metronidazole 0.4g/time, qd

Quintuple method group
Vitamin ADRUG

Vitamin A 5,000 units/time, qd

Quintuple method group
Folic acidDRUG

Folic acid 5 mg/time, qd

Quintuple method group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-80 years at the time of signing the informed consent form;
  • Patients with histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);
  • Patients with liver metastases found by imaging examination, and liver metastases cannot be radically resected, Or relapse liver metastasis;
  • At least one measurable metastatic lesion as defined by RECIST version 1.1;
  • Genetic test results are Kras/Nras/Braf wild-type or mutation type;
  • ECOG performance status 0-1;
  • Except for the liver, other organs function well;
  • Willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures.

You may not qualify if:

  • Patients with non-primary intestinal cancer;
  • Patients whose primary tumor as well as metastases can be radically resected by surgery;
  • One or several serious allergies to each drug required for the trial;
  • Combined with respiratory, circulatory, urinary, hematopoietic and other serious underlying diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

Location

MeSH Terms

Interventions

OxaliplatinS 1 (combination)TegafurgimeracilCetuximabMetronidazoleVitamin AFolic Acid

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsFluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsNitroimidazolesNitro CompoundsImidazolesAzolesRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Zhang Zhongguo, Doctor

CONTACT

15840217908Zhangzhongguoln@163.com

Yang Xiaoyu, Doctor

CONTACT

18900918453yangxiaoyu1368@163.com

Study Design

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

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 20, 2023

Study Start

March 15, 2023

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

CN(1)