Wild-type KRAS,NRAS and BRAF V600E Metastatic Colorectal CancerNCT04718038
Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer
An observational study of Wild-type KRAS,NRAS and BRAF V600E Metastatic Colorectal Cancer, run by Henan Cancer Hospital.
Trial summary
The aim of this study was to evaluate the efficacy and safety of continuing cetuximab combined with chemotherapy after first-line progression in wild-type KRAS,NRAS and BRAF colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Wild-type KRAS,NRAS and BRAF V600E Metastatic Colorectal Cancer
- What is being tested?
- Cetuximab combind mFOLFOX6/FOLFIRI
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Sep 2020
- How long will I take part?
- 2 Years
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with metastatic colorectal cancer
Who may be able to join
- Patients volunteered to participate in this study and signed informed consent.
- Patients with wild-type KRAS,NRAS and BRAF V600E metastatic colorectal adenocarcinoma confirmed by histology and genetic testing.
- Patients with metastatic colorectal cancer (stage IV) confirmed by imaging (CT/MRI) with measurable lesions (according to RECIST 1.1 criteria)
- Patients who had previously received first-line standard chemotherapy in combination with cetuximab, or/and maintenance therapy with cetuximab for disease progression.The standard treatment regimens include XELOX, FOLFOX, and FOLFIRI.
- 5.18-70 years old ;ECOG PS score: 0~1;Life expectancy ≥ 12 weeks. 6. Provide histological specimens for secondary detection: primary lesion or metastatic lesion.
- 7.The main organ function meets the following criteria within 7 days before treatment:
- (1)Blood routine examination criteria (without blood transfusion within 14 days): Hemoglobin (HB) ≥ 90g / L; The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥ 80 × 109 / L; (2) Biochemical examinations must meet the following criteria: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) ≤ 2.5 ULN; serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60ml / min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- 8.Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients; men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
Who cannot join
- Exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)].
- Radiation therapy on tumor target was performed within 4 weeks before enrollment.
- Unmitigated toxic reactions higher than CTC AE(4.0) grade 2 or above due to any prior treatment, excluding alopecia and neurotoxicity ≤ grade 2 due to oxaliplatin.
- Any severe and/or uncontrolled disease, including:
- patients with hypertension who are not well controlled by antihypertensive drug (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg).
- with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification).
Show all 20Show fewer
- Severe or uncontrolled disease or active infection (≥CTCAE grade 2 infection), which the investigator believes may increase the risk associated with study participation, study drug administration, or affect the subject's ability to receive study medication.
- Renal failure requires hemodialysis or peritoneal dialysis.
- a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- Patients with diabetes who have poor glycemic control (fasting blood glucose (FBG) > 10 mmol/L); subjects with active, known or suspected autoimmune diseases. Subjects with type 1 diabetes, residual hypothyroidism caused by autoimmune thyroiditis requiring hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be enrolled.
- patients with seizures and requiring treatment.
- Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.
- Patients who underwent surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to enrollment.
- In the 4 weeks prior to enrollment, patients with any bleeding event ≥ CTCAE 3 have unhealed wounds, ulcers or fractures.
- Overactive/venous thrombosis events within 3 months, such as cerebrovascular accidents (including transient ischemic attacks), deep static Pulmonary thrombosis and pulmonary embolism.
- those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder.
- Patients with brain metastases.
- Patients who have participated in other clinical trials of anti-tumor drugs within four weeks.
- According to the investigator's judgment, there is a concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study.
- Cannot perform biopsy to provide histological specimens.
About this study
Official title: A Clinical Study of Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer
The aim of this study was to evaluate the efficacy and safety of continuing cetuximab combined with chemotherapy after first-line progression in wild-type KRAS,NRAS and BRAF colorectal cancer.
Read the detailed description
In addition to the sequential therapeutic schedule of offering maintenance therapy and reintroduction of chemotherapy regimens to patients with nonresectable mCRC, multiline treatment strategy of continuing bevacizumab after progression to first-line bevacizumab plus chemotherapy demonstrated optimal clinical benefits in prolonging progression-free survival (PFS) and overall survival (OS) . Continuing cetuximab after progression to first-line cetuximab is also a promising strategy. The underlying hypothesis is that a sustained inhibition of EGFR signaling with cetuximab would continuously eliminate sensitive clones of RAS wild-type tumor. The present phase 2 clinical trial evaluated standard fluoropyrimidine-based chemotherapy combined with cetuximab among patients with wild-type KRAS, NRAS and BRAF V600E mCRC who had progressed after cetuximab plus standard chemotherapy in the first-line setting.
- Being tested
- Cetuximab combind mFOLFOX6/FOLFIRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab combind mFOLFOX6/FOLFIRIDrug
Cetuximab 500mg/m2 ivgtt 2h d1 ,q14d;mFOLFOX6: Oxaliplatin 85mg/m2 ivgtt 2h d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1, 5-Fu 2.4/m2 CIV 46h, q14d; FOLFIRI: CPT-11 180mg/m2 ivgtt 60-90mins d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1,5-Fu 2.4/m2 CIV 46-48h, q14d
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
The time from randomization to documented disease progression or death from any cause
Measured: 2 years
Secondary outcomes (3)
Overall Survial(OS)
The time from randomization to death from any cause
Measured: 2 years
ORR
The percentage of complete or partial responses
Measured: 2 years
Safety
assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jul 2016
- Primary completion1 Feb 2018
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wild-type KRAS,NRAS and BRAF V600E Metastatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718038
- Sponsor's protocol ID
- HNCH-GI-100
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04718038
- Acronym / sponsor ID
- HNCH-GI-100
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Sep 2020
- First posted
- 22 Jan 2021 (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.
The aim of this study was to evaluate the efficacy and safety of continuing cetuximab combined with chemotherapy after first-line progression in wild-type KRAS,NRAS and BRAF colorectal cancer.
Detailed description
In addition to the sequential therapeutic schedule of offering maintenance therapy and reintroduction of chemotherapy regimens to patients with nonresectable mCRC, multiline treatment strategy of continuing bevacizumab after progression to first-line bevacizumab plus chemotherapy demonstrated optimal clinical benefits in prolonging progression-free survival (PFS) and overall survival (OS) . Continuing cetuximab after progression to first-line cetuximab is also a promising strategy. The underlying hypothesis is that a sustained inhibition of EGFR signaling with cetuximab would continuously eliminate sensitive clones of RAS wild-type tumor. The present phase 2 clinical trial evaluated standard fluoropyrimidine-based chemotherapy combined with cetuximab among patients with wild-type KRAS, NRAS and BRAF V600E mCRC who had progressed after cetuximab plus standard chemotherapy in the first-line setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer
Key inclusion criteria (8 listed)
- Patients volunteered to participate in this study and signed informed consent.
- Patients with wild-type KRAS,NRAS and BRAF V600E metastatic colorectal adenocarcinoma confirmed by histology and genetic testing.
- Patients with metastatic colorectal cancer (stage IV) confirmed by imaging (CT/MRI) with measurable lesions (according to RECIST 1.1 criteria)
- Patients who had previously received first-line standard chemotherapy in combination with cetuximab, or/and maintenance therapy with cetuximab for disease progression.The standard treatment regimens include XELOX, FOLFOX, and FOLFIRI.
- 5.18-70 years old ;ECOG PS score: 0~1;Life expectancy ≥ 12 weeks. 6. Provide histological specimens for secondary detection: primary lesion or metastatic lesion.
Key exclusion criteria (20 listed)
- Exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement membrane)].
- Radiation therapy on tumor target was performed within 4 weeks before enrollment.
- Unmitigated toxic reactions higher than CTC AE(4.0) grade 2 or above due to any prior treatment, excluding alopecia and neurotoxicity ≤ grade 2 due to oxaliplatin.
- Any severe and/or uncontrolled disease, including:
- Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.
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 |
|---|---|---|
| Cetuximab combind mFOLFOX6/FOLFIRICetuximab 500mg/m2 ivgtt 2h d1 ,q14d;mFOLFOX6: Oxaliplatin 85mg/m2 ivgtt 2h d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1, 5-Fu 2.4/m2 CIV 46h, q14d; FOLFIRI: CPT-11 180mg/m2 ivgtt 60-90mins d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1,5-Fu 2.4/m2 CIV 46-48h, q14d | Drug | – |
Primary outcome
Progression-free survival(PFS)
Time frame: 2 years
The time from randomization to documented disease progression or death from any cause
3 secondary outcomes
Overall Survial(OS)
Time frame: 2 years
ORR
Time frame: 2 years
Safety
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wild-type KRAS,NRAS and BRAF V600E Metastatic Colorectal Cancer, run by Henan Cancer Hospital.
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 8 inclusion and 20 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 2 years). 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 22 Jan 2021.