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Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes

ConditionLiver Metastases of Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years (including 18 and 75 years);

ECOG PS 0 or 1;

Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;

Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;

Disqualifiers

Pregnant or lactating women;

Patients with a known history of allergy to any investigative drug, similar drug, or excipient;

Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;

Patients with a history of thromboembolism, except thrombosis caused by PICC;

Trial design

Design model

Single group

Treatments tested in this trial

  • Capecitabine

    Drug

    1000mg/m2, bid, d1-d14，q3w，1cycle

  • oxaliplatin

    Drug

    130mg/m2, ivgtt, d1，q3w，1cycle

  • Cetuximab

    Drug

    cetuximab 500mg/m2, q2w

  • Oxaliplatin

    Drug

    85mg/m2, d1,q2w

  • Leucovorin

    Drug

    400mg/m2, d1,q2w

  • 5-FU

    Drug

    400mg/m2，d1,q2w

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: cetuximab+chemotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

Time frame
every 2 weeks

Secondary outcomes

1

overall survival

Time frame
Around 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: