NCT04241731

Brief Summary

Maintenance treatment can extend patient survival and improve patient quality of life. Bevacizumab alone or capecitabine combined with bevacizumab as a maintenance treatment have been widely used in clinical practice. In contrast, there are little datas of cetuximab as a maintenance treatment. The purpose of this study is to evaluate efficacy and safety of Raltitrexed plus Cetuximab as the maintenance treatment, and to provide a new choice for RAS wild-type colorectal cancer patients after advanced first-line chemotherapy.

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
50

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_2 colorectal-cancer

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

Study Start

First participant enrolled

November 28, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

January 23, 2020

Last Update Submit

August 27, 2021

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • The time from the beginning of first-line treatment until the disease progresses.

    Progression Free Survival 1.

    24 months

  • The time from the beginning of maintenance treatment until the disease progresses.

    Progression Free Survival 2.

    24 months

Secondary Outcomes (3)

  • Overall survival (OS)

    24 months

  • Incidence of Treatment-Emergent Adverse Events Based on NCI-CTC 4.0

    24 months

  • Quality of life score

    24 months

Study Arms (1)

Raltitrexed Plus Cetuximab

EXPERIMENTAL

Raltitrexed Plus Cetuximab

Drug: RaltitrexedDrug: Cetuximab

Interventions

RaltitrexedDRUG

Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.

Raltitrexed Plus Cetuximab
CetuximabDRUG

Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.

Raltitrexed Plus Cetuximab

Eligibility Criteria

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

You may qualify if:

  • years old, no gender restriction;
  • RAS wild-type
  • Unresectable metastatic colorectal cancer confirmed by histopathology and / or cytology;
  • Disease stable or improved while on first-line use of FOLFOX/FOLFIRI with cetuximab for 4-6 months;
  • At least one measurable objective tumor lesion by spiral CT scan，the longest diameter measured ≧ 10 mm，or by conventional CT scan，the diameter measured ≧ 20 mm.
  • Eastern Cooperative Oncology Group (ECOG) general status score is 0-2;
  • Life expectancy of at least 3 months;
  • Blood routine, liver and kidney function within the 7 days before screening meet the following criteria: Absolute neutrophil count ≥ 1.5x10\^9 / L; hemoglobin ≥ 9.0 g / dl; platelet count ≥ 80 x10\^9 / L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN (≤5 x ULN in patients with liver metastases); ≤3 x ULN in patients with liver metastases (≤5 x ULN in patients with liver metastases); serum creatinine ≤1.5 x ULN;
  • Agree to sign informed consent.

You may not qualify if:

  • BRAF mutant
  • Symptomatic brain or meningeal metastases (unless patients receive treatment\> 6 months, imaging results are negative within 4 weeks before joining the study, and tumor-related clinical symptoms are stable before joining the study);
  • Previous malignant disease within five years, with the exception of the cured primary cervical cancer or basal cell carcinoma of the skin;
  • Chronic intestinal disease, infectious intestinal disease, intestinal obstruction, active clinical severe infection and other diseases;
  • With ascites
  • Substance abuse and medical, psychological or social conditions that may interfere with the participation of patients in the study or influence the evaluation of the results of the study;
  • Unsuitable for the study or other chemotherapy determined by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

raltitrexedCetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Liangjun Zhu

    Jiangsu Cancer Institute & Hospital

    STUDY CHAIR

Central Study Contacts

Liangjun Zhu

CONTACT

+8613905199123zhulj98@foxmail.com

Sheng Li

CONTACT

+8613770768636lihsh198@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ward Director of Internal Medicine

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 27, 2020

Study Start

November 28, 2019

Primary Completion

November 28, 2021

Study Completion

November 28, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

CN(1)