Colonic NeoplasmsPhase 2CIFOXRCNCT05468177
Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Right-Sided Colon Cancer
A Phase 2 study testing neoadjuvant chemotherapy in people with Colonic Neoplasms, run by Tongji Hospital at 1 site in China.
Trial summary
We plan to evaluate the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in the treatment of RAS/BRAF WT locally advanced or metastatic right colon cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Jun 2025
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RAS and BARF wild-type right colon adenocarcinoma (cecum, ascending colon, transverse colon excluding splenic flexure) confirmed by histopathology;
- Locally advanced right colon cancer should be assessed as T3 (invading muscularis propria ≥5mm) or T4 according to abdominal CT;
- Metastatic right colon cancer should conforms to the definition of oligometastasis of colorectal cancer in ESMO guidelines: the number of organs involved is ≤2 (occasionally 3), and the number of metastases is usually ≤5 or occasionally more.
- At least one measurable lesion according to RECIST1.1;
- ECOG score 0-1;
- The expected survival time is more than 3 months;
- Adequate organ function: total bilirubin ≤1.5 x upper limit of normal (ULN) , aspartate aminotransferase and alanine aminotransferase ≤2.5 x ULN (if patient with liver metastasis, total bilirubin ≤3 x ULN, aminotransferase and alanine aminotransferase ≤5x ULN) ,alkaline phosphatase ≤2.5 x ULN (if liver metastases≤5x ULN, if bone metastases ≤10 x ULN);LDH < 1500 U/L;Serum creatinine≤1.5 x ULN l or creatinine clearance rate ≤ 60 mL /min;ANC≥1.5×109 /L, platelet count ≥75×109 /L, Hb ≥90 g/L, WBC ≥3.0×109 /L;
- Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent.
Who cannot join
- 1.Early stage right colon cancer. 2. Received chemotherapy or biotherapy in the past . 3. uncontrollable infection, or received antibiotic treatment within 72 hours prior to receive chemotherapy; 4. Myelodysplastic syndrome or other hematopoietic abnormalities; 5. Other malignant tumors (except carcinoma in situ and basal cell carcinoma) during this year; 6. Patients with central nervous system metastasis; 7.≥ CTCAE Grade 2 unrecovered AEs due to prior treatment (excluding anemia, hair loss, skin pigmentation).Patients with unrecovered neurotoxicity ≥ CTCAE grade 3 due to platinum-based drugs.
- 8. Other diseases, such as active tuberculosis, infect HIV, AIDS, hepatitis B (patient withHBV-DNA <500IU/ml,and normal liver function can be included), positive test for hepatitis C virus, uncorrectable electrolyte disorder;ascites, pleural effusion or hydropericardium that required drainage in the past 4 weeks.With intestinal obstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure , or cerebrovascular disease.
- 9. Uncontrolled diabetes was defined as HbA1c >7.5% after the use of antidiabetic drugs, or uncontrolled hypertension was defined as systolic/diastolic blood pressure >140/90 mmHg after the use of antihypertensive drugs.
- 10. Myocardial infarction,severe/unstable angina, NYHA III or IV congestive heart failure within the past 12 months.
- 11. Patients who are allergic to the therapeutic drugs in this study; 12. With mental or nervous system diseases who are unable to cooperate; 13. Pregnant or lactating women;Childbearing age women refuse to accept contraceptive measures; 14.Active autoimmune disease, a history of autoimmune disease, accepting corticosteroid or immunosuppressants, or accepting hormone replacement therapy (such as thyroxine, insulin, etc).
- 15. Received live vaccine within 30 days (seasonal influenza vaccine is allowed because it is inactivated) 16.Treated with any other investigational drug or participated in another interventional clinical trial within 30 days of the screening period; undergo surgery within 30 days (except for diagnostic biopsy, surgical incision should be completely healed prior to administration of the study drug).Received radiation therapy within 30 days.
- 17. Other serious medical conditions made the investigator consider the patients ineligible for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
Guihua Wang, ghwang@tjh.tjmu.edu.cn
About this study
Official title: A Multiple-Center,Single-arm Clinical Study of Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Locally Advanced or Metastatic Right-Sided Colon Cancer
We plan to evaluate the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in the treatment of RAS/BRAF WT locally advanced or metastatic right colon cancer
Read the detailed description
According to the World Health Organization, colorectal cancer (CRC) is the third most common cancer in men and the second most common cancer in women worldwide. CRC is estimated to kill 551,269 patients worldwide each year, accounting for 5.8% of cancer deaths.Despite recent development in treatment, locally advanced or metastatic colon cancer (CC) represents a major therapeutic challenge. Presently, the standard therapeutic approach for CC is surgery and/or adjuvant chemotherapy. Nevertheless,several studies showed that neoadjuvant chemotherapy (NAC) is a more effective treatment option.Immune checkpoint inhibition (ICI) directed against programmed death-1 (PD-1) is highly effective and has become the standard of care for patients with dMMR metastatic colorectal cancers (mCRCs). In contrast, the same regimens have shown poor response rates in patients with pMMR mCRCs.Due to the high ORR rate of cetuximab combined with chemotherapy and the microenvironment with high immune infiltration of right colon cancer, it may be more sensitive to ICI.
This study consisted of two phases: phase I consisted of 25 patients; if > 11 patients responded, the trial will continue to phase II, and a total of 66 patients will be enrolled.
- Conditions
- Colonic Neoplasms
- Being tested
- neoadjuvant chemotherapy
- Keywords
- neoadjuvant chemotherapy, cetuximab, right colon cancer, immunotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapyCombination product
Cetuximab: 500mg/m2,day1, every 2 weeks. mFOLFOX: oxaliplatin 85mg/m2, day 1;LV 400mg/m2, day 1;5-FU 400mg/m2, day 1, then 1200mg/ (m2•d) ×2days(total 2400mg/m2, infusion 46-48h) (every 2 weeks).
Anti-PD-1(Sintilimab Injection):200mg every 3 weeks. Surgery will be performed after 4 cycles for locally advanced or initially resectable metastatic right colon cancer.If the initial unresectable metastatic right colon cancer were converted into resectable metastases, and surgery will be performed. Patients who failed to convert after 6 cycles of treatment will be withdrawn from the study.Cetuximab +mFOLFOX was treat for 8 cycles, and Anti-PD-1 was treated for one year in the perioperation period unless disease progression, toxicity intolerance, initiation of new anti-tumor therapy.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy | Experimental | Cetuximab+ mFOLFOX+ Anti-PD-1+Surgery Receives: Combination Product: neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
percentage of patients showing complete response (CR) or partial response (PR) as best response according to RECIST1.1
Measured: an average of 6 to 12 weeks after surgery
Secondary outcomes (2)
disease free survival (DFS)
DFS is defined as the time from treatment initiation to the date of first documentation of disease recurrence or death due to any cause
Measured: UP to 3 years
R0 resection rate
The percentage of patients whose post-operative pathology indicate negative margin is observed under microscope
Measured: an average of 6 to 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huangshi Central Hospital, Central Hospital of Xiaogan, Ezhou Central Hospital, Jingzhou Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468177
- Sponsor's protocol ID
- TJ-IRB20220165
- Acronym
- CIFOXRC
- Status last verified
- Jan 2022
- First submitted
- 19 Jul 2022
- Last updated
- 21 Jul 2022
- 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 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Center,Single-arm Clinical Study of Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Locally Advanced or Metastatic Right-Sided Colon Cancer
- ClinicalTrials.gov ID
- NCT05468177
- Acronym / sponsor ID
- CIFOXRC / TJ-IRB20220165
- Conditions
- Colonic Neoplasms
- Keywords
- neoadjuvant chemotherapy, cetuximab, right colon cancer, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Huangshi Central Hospital, Central Hospital of Xiaogan, Ezhou Central Hospital, Jingzhou Central Hospital
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Jul 2022 (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.
We plan to evaluate the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in the treatment of RAS/BRAF WT locally advanced or metastatic right colon cancer
Detailed description
According to the World Health Organization, colorectal cancer (CRC) is the third most common cancer in men and the second most common cancer in women worldwide. CRC is estimated to kill 551,269 patients worldwide each year, accounting for 5.8% of cancer deaths.Despite recent development in treatment, locally advanced or metastatic colon cancer (CC) represents a major therapeutic challenge. Presently, the standard therapeutic approach for CC is surgery and/or adjuvant chemotherapy. Nevertheless,several studies showed that neoadjuvant chemotherapy (NAC) is a more effective treatment option.Immune checkpoint inhibition (ICI) directed against programmed death-1 (PD-1) is highly effective and has become the standard of care for patients with dMMR metastatic colorectal cancers (mCRCs). In contrast, the same regimens have shown poor response rates in patients with pMMR mCRCs.Due to the high ORR rate of cetuximab combined with chemotherapy and the microenvironment with high immune infiltration of right colon cancer, it may be more sensitive to ICI.
This study consisted of two phases: phase I consisted of 25 patients; if > 11 patients responded, the trial will continue to phase II, and a total of 66 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy | Experimental | Combination Product: neoadjuvant chemotherapyCetuximab+ mFOLFOX+ Anti-PD-1+Surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- RAS and BARF wild-type right colon adenocarcinoma (cecum, ascending colon, transverse colon excluding splenic flexure) confirmed by histopathology;
- Locally advanced right colon cancer should be assessed as T3 (invading muscularis propria ≥5mm) or T4 according to abdominal CT;
- Metastatic right colon cancer should conforms to the definition of oligometastasis of colorectal cancer in ESMO guidelines: the number of organs involved is ≤2 (occasionally 3), and the number of metastases is usually ≤5 or occasionally more.
- At least one measurable lesion according to RECIST1.1;
- ECOG score 0-1;
Key exclusion criteria (7 listed)
- 1.Early stage right colon cancer. 2. Received chemotherapy or biotherapy in the past . 3. uncontrollable infection, or received antibiotic treatment within 72 hours prior to receive chemotherapy; 4. Myelodysplastic syndrome or other hematopoietic abnormalities; 5. Other malignant tumors (except carcinoma in situ and basal cell carcinoma) during this year; 6. Patients with central nervous system metastasis; 7.≥ CTCAE Grade 2 unrecovered AEs due to prior treatment (excluding anemia, hair loss, skin pigmentation).Patients with unrecovered neurotoxicity ≥ CTCAE grade 3 due to platinum-based drugs.
- 8. Other diseases, such as active tuberculosis, infect HIV, AIDS, hepatitis B (patient withHBV-DNA <500IU/ml,and normal liver function can be included), positive test for hepatitis C virus, uncorrectable electrolyte disorder;ascites, pleural effusion or hydropericardium that required drainage in the past 4 weeks.With intestinal obstruction, gastrointestinal bleeding, pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure , or cerebrovascular disease.
- 9. Uncontrolled diabetes was defined as HbA1c >7.5% after the use of antidiabetic drugs, or uncontrolled hypertension was defined as systolic/diastolic blood pressure >140/90 mmHg after the use of antihypertensive drugs.
- 10. Myocardial infarction,severe/unstable angina, NYHA III or IV congestive heart failure within the past 12 months.
- 11. Patients who are allergic to the therapeutic drugs in this study; 12. With mental or nervous system diseases who are unable to cooperate; 13. Pregnant or lactating women;Childbearing age women refuse to accept contraceptive measures; 14.Active autoimmune disease, a history of autoimmune disease, accepting corticosteroid or immunosuppressants, or accepting hormone replacement therapy (such as thyroxine, insulin, etc).
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 |
|---|---|---|
| neoadjuvant chemotherapyCetuximab: 500mg/m2,day1, every 2 weeks. mFOLFOX: oxaliplatin 85mg/m2, day 1;LV 400mg/m2, day 1;5-FU 400mg/m2, day 1, then 1200mg/ (m2•d) ×2days(total 2400mg/m2, infusion 46-48h) (every 2 weeks). Anti-PD-1(Sintilimab Injection):200mg every 3 weeks. Surgery will be performed after 4 cycles for locally advanced or initially resectable metastatic right colon cancer.If the initial unresectable metastatic right colon cancer were converted into resectable metastases, and surgery will be performed. Patients who failed to convert after 6 cycles of treatment will be withdrawn from the study.Cetuximab +mFOLFOX was treat for 8 cycles, and Anti-PD-1 was treated for one year in the perioperation period unless disease progression, toxicity intolerance, initiation of new anti-tumor therapy. | Combination product | neoadjuvant chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: an average of 6 to 12 weeks after surgery
percentage of patients showing complete response (CR) or partial response (PR) as best response according to RECIST1.1
2 secondary outcomes
disease free survival (DFS)
Time frame: UP to 3 years
R0 resection rate
Time frame: an average of 6 to 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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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?
A Phase 2 study testing neoadjuvant chemotherapy in people with Colonic Neoplasms, run by Tongji Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guihua Wang (+86-027-83665215, ghwang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: an average of 6 to 12 weeks after surgery). 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 21 Jul 2022.