Cetuximab with anti-PD-1 and chemotherapy for right-sided colon cancer
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
Run by Tongji Hospital · NCT05468177 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a new combination of cetuximab, anti-PD-1, and chemotherapy can help people with advanced right-sided colon cancer do better than with standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation, cetuximab |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05468177 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with RAS and BRAF wild-type right colon adenocarcinoma who have locally advanced or oligometastatic disease.
✕Probably not a fit
Patients with non-RAS/BRAF wild-type colon cancer or those with severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in treating RAS/BRAF wild-type locally advanced or metastatic right colon cancer. It aims to determine if this combination can improve outcomes compared to standard treatments. The trial consists of two phases, with phase I assessing initial responses in 25 patients before proceeding to phase II, which will enroll a total of 66 patients if sufficient responses are observed. The approach leverages the potential sensitivity of right colon cancer to immune checkpoint inhibitors due to its unique microenvironment.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced right-sided colon cancer.
How similar studies have gone: While there have been studies on cetuximab and immunotherapy in colorectal cancer, this specific combination approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. RAS and BARF wild-type right colon adenocarcinoma (cecum, ascending colon, transverse colon excluding splenic flexure) confirmed by histopathology; 2. Locally advanced right colon cancer should be assessed as T3 (invading muscularis propria ≥5mm) or T4 according to abdominal CT; 3. 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. 4. At least one measurable lesion according to RECIST1.1; 5. ECOG score 0-1; 6. The expected survival time is more than 3 months; 7. 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; 8. Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent. Exclusion Criteria: * 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.
Where it's running
-
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Guihua Wang
- Email: ghwang@tjh.tjmu.edu.cn
- Phone: +86-027-83665215
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer
This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.
-
Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer
In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.
-
Cetuximab bioequivalence test in healthy men
This study tests whether a cetuximab injection is bioequivalent to Erbitux in healthy men to see if they behave the same in the body.
-
HSK42360-Na tablets with cetuximab in BRAF V600-mutant metastatic colorectal cancer
This Phase 1/2 study tests whether HSK42360-Na tablets with cetuximab, with or without standard chemotherapy, are safe and may help people whose colorectal cancer has a BRAF V600 mutation that has spread.
-
Neoadjuvant therapy with encorafenib plus cetuximab N01 and mFOLFOX6 in locally advanced BRAF V600E-mutant colorectal cancer
This trial tests a targeted, pre-surgery treatment to see if it improves the chance of long-term control in adults with locally advanced BRAF V600E-mutant colorectal cancer.
-
Petosemtamab plus chemotherapy vs standard chemo plus cetuximab or bevacizumab in RAS/BRAF WT colorectal cancer
This phase 3 trial tests whether adding petosemtamab to standard chemotherapy works better than the usual chemo plus cetuximab or bevacizumab for people with recurrent, unresectable, or metastatic colorectal cancer that is KRAS/NRAS/BRAF wild type.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.