A Phase 2 interventional study of Toripalimab and Cetuximab in Colorectal Cancer (CRC), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
Among 58 studies testing cetuximab in Colonic Neoplasms — 7 open to participants now, 12 under way, 4 of them phase 3. Cetuximab · Colonic Neoplasms.
Among the 58 studies testing cetuximab in Colonic Neoplasms, this one is the 28th largest by planned enrollment of the 56 interventional ones, is the only one that started in 2026, is one of 34 in phase 2, reaches primary completion later than 8 of the 11 other live ones, and was the 58th registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 46 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →7 of the 58 studies testing cetuximab in Colonic Neoplasms are open now, in 12 countries. Each count lists the studies.
Cetuximab: first FDA approval 2004 (ERBITUX), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 326 Colonic Neoplasms studies recruiting now, 203 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →58 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2026.
Median enrollment 46 across the 56 interventional studies. Of the 39 that completed or were terminated, 16 (41%) have results posted.
4 of 58 have an industry lead sponsor. The 10 most frequent:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 393 studies on the registry; 280 are open to participants now.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences has 5 studies filed under Colonic Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 58 studies testing cetuximab in Colonic Neoplasms, from their registry updates:
This phase II, single-arm clinical study aims to evaluate the efficacy and safety of toripalimab combined with cetuximab and irinotecan as second-line treatment for patients with advanced right-sided colon cancer with wild-type RAS and BRAF genes.
The study will enroll up to 46 adult patients with recurrent or metastatic right-sided colon cancer whose disease has progressed after first-line systemic therapy. Eligible patients must have wild-type RAS and BRAF genes and must not have previously received anti-EGFR antibodies or irinotecan.
All participants will receive toripalimab, cetuximab, and irinotecan by intravenous infusion every two weeks. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.
The primary outcome is the objective response rate (ORR), assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary outcomes include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and treatment safety. Exploratory analyses will investigate potential biomarkers associated with treatment response using blood, tumor tissue, and other biological samples.
This study seeks to generate clinical evidence regarding the potential efficacy and safety of this combination therapy in patients with advanced right-sided colon cancer who require second-line treatment.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 46 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 393 studies on the registry; 280 are open to participants now.
Compared within Colonic Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Colorectal Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria to be eligible for this study:
Adequate organ function, defined by the following laboratory criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive toripalimab, cetuximab, and irinotecan intravenously every two weeks until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.
Drug: Toripalimab · Drug: Cetuximab · Drug: Irinotecan
Toripalimab will be administered intravenously at a dose of 3 mg/kg every 2 weeks. The first infusion will last at least 60 minutes. Subsequent infusions may be shortened to at least 30 minutes if tolerated. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.
Cetuximab will be administered intravenously at a dose of 500 mg/m² every 2 weeks in combination with toripalimab and irinotecan. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.
Irinotecan will be administered intravenously at a dose of 180 mg/m² every 2 weeks in combination with toripalimab and cetuximab. Treatment will continue until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation.
Objective Response Rate (ORR)
The percentage of participants who achieve a complete response (CR) or partial response (PR), as assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: From baseline until disease progression or initiation of new anticancer therapy, assessed up to approximately 24 months.
Duration of Response (DoR)
Duration of response is defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression or death from any cause, whichever occurs first, among participants achieving CR or PR, according to RECIST version 1.1.
Time frame: From the first documented CR or PR until disease progression or death, assessed up to approximately 24 months.
Disease Control Rate (DCR)
The percentage of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD), as assessed by investigators according to RECIST version 1.1.
Time frame: From baseline until disease progression or initiation of new anticancer therapy, assessed up to approximately 24 months.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Overall Survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death from any cause.
Time frame: From the first dose of study treatment until death from any cause, assessed up to approximately 24 months.
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The number and percentage of participants experiencing adverse events (AEs) or serious adverse events (SAEs) will be assessed. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Safety assessments will include laboratory tests, vital signs, electrocardiograms, and physical examinations.
Time frame: From the first dose of study treatment through 90 days after the last dose.
Change From Baseline in Plasma Circulating Tumor DNA Variant Allele Frequency (VAF) at Week 8
Plasma circulating tumor DNA (ctDNA) will be assessed using targeted next-generation sequencing (NGS) at baseline and Week 8. The maximum variant allele frequency (VAF) among predefined tumor-associated somatic variants will be recorded for each participant at each time point. VAF will be expressed as a percentage. The change from baseline will be calculated as the Week 8 VAF minus the baseline VAF and reported in percentage points. Negative values indicate a reduction in ctDNA VAF.
Time frame: Baseline and Week 8 after the first dose of study treatment.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Toripalimab · Cetuximab · Irinotecan
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →