Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thalidomide+cetuximab+FOLFOX/FOLFIRI.
- Who it may be relevant to
- Registry conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Thalidomide+cetuximab+FOLFOX/FOLFIRI
Thalidomide+cetuximab+FOLFOX/FOLFIRI
Primary outcome measures
- ETS [Time frame: 8 weeks]
Secondary outcome measures (3)
- ORR [Time frame: 8 weeks]
- DCR [Time frame: 8 weeks]
- PFS [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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;
- Have not received systematic chemotherapy before;
- Did not receive cetuximab treatment;
- Liver, kidney and bone marrow functions are basically normal;
- The clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks;
- Voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent.
Exclusion criteria
- 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;
- People with a clear history of drug allergy or allergic constitution;
- Patients participating in other clinical trials;
- Other conditions in which the patient was considered inappropriate to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the second affiliated hospital of Army medical university — Chongqing
Identifiers
NCT: NCT06279351 · Thalicolorectal