Health TrialsbyHealthPanel

Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer

ConditionThalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXinqiao Hospital of Chongqing

About this trial

1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application. 2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing;

Physical state is good: PS 0-2;

Expected survival of more than 3 months;

Aged 18-75 years old;

Disqualifiers

Patients with severe dysfunction of vital organs (heart, liver, kidney);

Patients with other malignant tumors;

Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test);

In the active phase of acute or chronic infectious diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thalidomide+cetuximab+FOLFOX/FOLFIRI

    Drug

    Thalidomide+cetuximab+FOLFOX/FOLFIRI

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Test groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

ETS

Early tumor shrinkage

Time frame
8 weeks

Secondary outcomes

1

ORR

Time frame
8 weeks
2

DCR

Time frame
8 weeks
3

PFS

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

Chongqing Medical University

Collaborator

Source ClinicalTrials.gov
Apply now