Colon CancerNCT06322147
Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer
An observational study of Colon Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Doublet or triplet chemotherapy combined with cetuximab
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: RAS/BRAF wild type unresectable liver metastasis right-sided colon cancer
Who may be able to join
- Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent;
- Male or female subjects > 18 years < 75 of age;
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ;
- Life expectancy of more than 3 months;
- Patients with pathologically confirmed metastatic colorectal liver metastases with molecular testing RAS/BRAF wild-type, MSS;
- At least one measurable lesion in liver metastases according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1;
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- No previous any systemic anticancer therapy; if received primary tumor surgery and postoperative adjuvant chemotherapy, more than 6 months from the end of the last chemotherapy;
- Liver metastases are initially unresectable, but can have the opportunity to achieve complete resection or NED status with conversion therapy;
- Patients have adequate bone marrow, hepatic and renal function;
Who cannot join
- Any evidence of extra-hepatic metastases, lymph node (including portal lymph nodes) metastases and primary tumor recurrence.
- The primary tumor cannot be completely resected;
- If the possibility of R0 transformation is achieved, the patient refuses surgery due to non-medical factors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of Shandong University
Jinan, Shandong, 250012
xiangling Wang, Dr., 8653182169841, xlwang71@163.com
Jing Hao
About this study
Official title: Doublet or Triplet Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF Wild Type Unresectable Liver Metastasis Right-sided Colon Cancer With Curative Intent：Multi-center, Ambispective Observational Trial
This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety.
Read the detailed description
Patients with colorectal liver-limited metastases (CLM) represent an exceptional subgroup with regards to the possible benefits of potentially curative multidisciplinary strategies, in which the upfront most active combination regimens are preferred to improve the rate of radical resection (R0) and NED (no evidence of disease). Unfortunately, Data are limited that specifically address the tumor location's impact on conversion therapy. As far as right-sided CRLM are concerned, much lower R0 after conversion therapy could be achieved when compared with left-sided CRLM. Furthermore, great controversies remain about the optimal conversion regimens in right-sided CRLM and the potential roles of anti-EGFR with regards to the different recommendations from NCCN, ESMO and CSCO guidelines. Chemotherapy plus cetuximab have the advantages in terms of response rate, early tumor shrinkage and depth of response, thus it is still of great value to explore the roles of cetuximab plus chemotherapy as conversion strategy in the right-sided RAS/BRAF wild type and MSS CRLM in the real world scenario.
This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety.
- Conditions
- Colon Cancer
- Being tested
- Doublet or triplet chemotherapy combined with cetuximab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doublet or triplet chemotherapy combined with cetuximabDrug
chemotherapy+cetuximab combination therapy，chemotherapy regimens include FOLFOX, FOLFIRI, XELOX, or mFOLFOXIRI.
Cetuximab first dose 400 mg/m2, followed by cetuximab 250 mg/m2 every 2 weeks;
mFOLFOX6: oxaliplatin 85 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1), and 5-FU 2400 mg/m2 CIV (46 h) for up to 12 cycles;
XELOX (biweekly): oxaliplatin 85 mg/m2 (day 1), capecitabine 1000 mg/m2, bid, d1-10;
FOLFIRI: irinotecan 180 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1), and 5-FU 2400 mg/m2 CIV (46 h), Up to 12 cycles;
mFOLFOXIRI: oxaliplatin 85 mg/m2 (day 1), irinotecan 150 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1) and 5-FU 2400 mg/m2 CIV (46 h).
| Study group | Role | What they receive |
|---|---|---|
| Doublet or triplet chemotherapy combined with cetuximab | Not described Receives: Drug: Doublet or triplet chemotherapy combined with cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
R0 resection rate upon conversion treatment with chemotherapy plus cetuximab
Measured: 1 year
Secondary outcomes (6)
Objective response rate
CR + PR rate according to RECIST
Measured: 1 year
Reported adverse events
Number of patients with adverse events and severity according to NCI CTC 4.0
Measured: 1 year
Progression free survival
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Measured: 2 year
no evidence of disease
the percentage of patients who had a curative liver treatment following protocol treatment
Measured: 1 year
depth of response
DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.
Measured: 1 year
Early Tumor Shrinkage
Early tumor shrinkage assessed by Response rate at week 8
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 posted20 Mar 2024
- Study start1 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322147
- Sponsor's protocol ID
- KYLL-202304-31
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doublet or Triplet Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF Wild Type Unresectable Liver Metastasis Right-sided Colon Cancer With Curative Intent：Multi-center, Ambispective Observational Trial
- ClinicalTrials.gov ID
- NCT06322147
- Acronym / sponsor ID
- KYLL-202304-31
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Mar 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.
This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety.
Detailed description
Patients with colorectal liver-limited metastases (CLM) represent an exceptional subgroup with regards to the possible benefits of potentially curative multidisciplinary strategies, in which the upfront most active combination regimens are preferred to improve the rate of radical resection (R0) and NED (no evidence of disease). Unfortunately, Data are limited that specifically address the tumor location's impact on conversion therapy. As far as right-sided CRLM are concerned, much lower R0 after conversion therapy could be achieved when compared with left-sided CRLM. Furthermore, great controversies remain about the optimal conversion regimens in right-sided CRLM and the potential roles of anti-EGFR with regards to the different recommendations from NCCN, ESMO and CSCO guidelines. Chemotherapy plus cetuximab have the advantages in terms of response rate, early tumor shrinkage and depth of response, thus it is still of great value to explore the roles of cetuximab plus chemotherapy as conversion strategy in the right-sided RAS/BRAF wild type and MSS CRLM in the real world scenario.
This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doublet or triplet chemotherapy combined with cetuximab | – | Drug: Doublet or triplet chemotherapy combined with cetuximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- RAS/BRAF wild type unresectable liver metastasis right-sided colon cancer
Key inclusion criteria (9 listed)
- Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent;
- Male or female subjects > 18 years < 75 of age;
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ;
- Life expectancy of more than 3 months;
- Patients with pathologically confirmed metastatic colorectal liver metastases with molecular testing RAS/BRAF wild-type, MSS;
Key exclusion criteria (3 listed)
- Any evidence of extra-hepatic metastases, lymph node (including portal lymph nodes) metastases and primary tumor recurrence.
- The primary tumor cannot be completely resected;
- If the possibility of R0 transformation is achieved, the patient refuses surgery due to non-medical factors.
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 |
|---|---|---|
| Doublet or triplet chemotherapy combined with cetuximabchemotherapy+cetuximab combination therapy，chemotherapy regimens include FOLFOX, FOLFIRI, XELOX, or mFOLFOXIRI. Cetuximab first dose 400 mg/m2, followed by cetuximab 250 mg/m2 every 2 weeks; mFOLFOX6: oxaliplatin 85 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1), and 5-FU 2400 mg/m2 CIV (46 h) for up to 12 cycles; XELOX (biweekly): oxaliplatin 85 mg/m2 (day 1), capecitabine 1000 mg/m2, bid, d1-10; FOLFIRI: irinotecan 180 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1), and 5-FU 2400 mg/m2 CIV (46 h), Up to 12 cycles; mFOLFOXIRI: oxaliplatin 85 mg/m2 (day 1), irinotecan 150 mg/m2 (day 1), 5-FU 400 mg/m2 (day 1), LV 400 mg/m2 (day 1) and 5-FU 2400 mg/m2 CIV (46 h). | Drug | Doublet or triplet chemotherapy combined with cetuximab |
Primary outcome
R0 resection rate
Time frame: 1 year
R0 resection rate upon conversion treatment with chemotherapy plus cetuximab
6 secondary outcomes
Objective response rate
Time frame: 1 year
Reported adverse events
Time frame: 1 year
Progression free survival
Time frame: 2 year
no evidence of disease
Time frame: 1 year
depth of response
Time frame: 1 year
Early Tumor Shrinkage
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Qilu Hospital of Shandong University 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 3 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Hao, PhD (18560082857, hedi0084@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 1 year). 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 20 Mar 2024.