Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal CancerPhase 2NCT06279351
Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
A Phase 2 study testing Thalidomide+cetuximab+FOLFOX/FOLFIRI in people with Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
- What is being tested?
- Thalidomide+cetuximab+FOLFOX/FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Army medical university
Chongqing, Chongqing Municipality, 400037
jianguo Sun, Phd, 023-68774490, sunjg09@aliyun.com
About this study
- 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.
- 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.
- Being tested
- Thalidomide+cetuximab+FOLFOX/FOLFIRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thalidomide+cetuximab+FOLFOX/FOLFIRIDrug
Thalidomide+cetuximab+FOLFOX/FOLFIRI
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Thalidomide+cetuximab+FOLFOX/FOLFIRI Receives: Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRI |
| control group | No intervention | cetuximab+FOLFOX/FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETS
Early tumor shrinkage
Measured: 8 weeks
Secondary outcomes (3)
ORR
Measured: 8 weeks
DCR
Measured: 8 weeks
PFS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start11 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Medical University
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
- Investigators
- rui kong, doctor, Principal investigator, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279351
- Sponsor's protocol ID
- Thalicolorectal
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06279351
- Acronym / sponsor ID
- Thalicolorectal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- Chongqing Medical University
- Study start
- 11 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRIThalidomide+cetuximab+FOLFOX/FOLFIRI |
| control group | No intervention | –cetuximab+FOLFOX/FOLFIRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide+cetuximab+FOLFOX/FOLFIRIThalidomide+cetuximab+FOLFOX/FOLFIRI | Drug | Test group |
Primary outcome
ETS
Time frame: 8 weeks
Early tumor shrinkage
3 secondary outcomes
ORR
Time frame: 8 weeks
DCR
Time frame: 8 weeks
PFS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
rui kong, doctor principal investigator
Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide+cetuximab+FOLFOX/FOLFIRI in people with Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianguo Sun, doctor (023-68774490, sunjianguo@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETS (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.