Colorectal Cancer (CRC)Phase 2NCT07896681
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
A Phase 2 study testing Toripalimab, Cetuximab and Irinotecan in people with Colorectal Cancer (CRC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Toripalimab, Cetuximab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2026to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for this study:
- Aged 18 years or older, regardless of sex.
- Patients with previously treated recurrent or metastatic right-sided colon cancer.
- Confirmed RAS and BRAF wild-type status based on molecular testing.
- Disease progression following first-line systemic anticancer therapy that did not include anti-EGFR monoclonal antibodies or irinotecan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a life expectancy of at least 3 months, and the ability to cooperate with efficacy and safety assessments.
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- At least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ function, defined by the following laboratory criteria:
- Absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥9 g/dL; serum albumin ≥3 g/dL.
- Thyroid-stimulating hormone (TSH) ≤1 × upper limit of normal (ULN), with T3 and T4 levels within normal ranges.
- Total bilirubin ≤1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2 × ULN.
- Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min.
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN, unless the participant is receiving anticoagulant therapy and PT is within the intended therapeutic range.
- Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
- No severe concomitant disease associated with a life expectancy of less than 5 years.
- Female participants of childbearing potential must have a negative pregnancy test. Female participants without childbearing potential are also eligible.
- Male participants of reproductive potential and female participants of childbearing potential must agree to use adequate contraception throughout the study and for 12 months after completion of study treatment.
- Provision of signed and dated written informed consent after receiving information about all relevant aspects of the study.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Agreement not to participate in any other clinical trials involving drugs or medical devices during the study period.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Pathologically confirmed intestinal tumors other than colon cancer, such as gastrointestinal stromal tumors.
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- History of or concurrent malignancies other than colon cancer, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma.
- Active autoimmune disease or a history of autoimmune disorders, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. Exceptions include autoimmune hypothyroidism controlled with a stable dose of thyroid hormone replacement therapy, type 1 diabetes mellitus controlled with a stable insulin regimen, vitiligo, or resolved childhood asthma/allergies requiring no intervention in adulthood.
- History of immunodeficiency, including positive human immunodeficiency virus (HIV) testing, acquired or congenital immunodeficiency disorders, organ transplantation, or allogeneic bone marrow transplantation.
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- History of interstitial lung disease (excluding radiation pneumonitis not requiring corticosteroid treatment) or noninfectious pneumonitis.
- Active tuberculosis infection identified through medical history or computed tomography (CT), a history of active tuberculosis within 1 year before enrollment, or a history of active tuberculosis more than 1 year before enrollment without adequate treatment.
- Active hepatitis B infection, defined as HBV DNA ≥2,000 IU/mL or ≥10⁴ copies/mL, or active hepatitis C infection, defined as positive hepatitis C antibody with HCV RNA above the lower limit of detection.
- Severe cardiac, pulmonary, or renal dysfunction.
- Uncontrolled hypertension despite antihypertensive treatment, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.
- History of psychotropic drug abuse, excessive alcohol consumption, or illicit drug use.
- Any other condition that, in the investigator's judgment, may compromise participant safety or compliance with study procedures, including severe concomitant diseases requiring treatment (including psychiatric disorders), clinically significant laboratory abnormalities, or relevant family or social factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Yongkun Sun, (+86)010-87788800, hsunyk@cicams.ac.cn
About this study
Official title: A Phase II Study of Toripalimab in Combination With Cetuximab and Irinotecan as Second-Line Treatment for Patients With Advanced Right-Sided RAS/BRAF Wild-Type Colon Cancer
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.
Read more
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.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Toripalimab, Cetuximab, Irinotecan
- Keywords
- Right-sided colon cancer, Advanced colon cancer, Metastatic colon cancer, RAS wild-type, BRAF wild-type, Second-line treatment, Toripalimab, Cetuximab, Irinotecan
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
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.
CetuximabDrug
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.
IrinotecanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab + Cetuximab + Irinotecan | Experimental | Participants will receive toripalimab, cetuximab, and irinotecan intravenously every two weeks until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation. Receives: Drug: Toripalimab; Drug: Cetuximab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline until disease progression or initiation of new anticancer therapy, assessed up to approximately 24 months.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first dose of study treatment through 90 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start3 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YONGKUN SUN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896681
- Sponsor's protocol ID
- NCCH0079
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Toripalimab in Combination With Cetuximab and Irinotecan as Second-Line Treatment for Patients With Advanced Right-Sided RAS/BRAF Wild-Type Colon Cancer
- ClinicalTrials.gov ID
- NCT07896681
- Acronym / sponsor ID
- NCCH0079
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Right-sided colon cancer, Advanced colon cancer, Metastatic colon cancer, RAS wild-type, BRAF wild-type, Second-line treatment, Toripalimab, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 27 Oct 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab + Cetuximab + Irinotecan | Experimental | Drug: Toripalimab, Drug: Cetuximab, Drug: IrinotecanParticipants will receive toripalimab, cetuximab, and irinotecan intravenously every two weeks until disease progression, unacceptable toxicity, or other protocol-defined reasons for discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Aged 18 years or older, regardless of sex.
- Patients with previously treated recurrent or metastatic right-sided colon cancer.
- Confirmed RAS and BRAF wild-type status based on molecular testing.
- Disease progression following first-line systemic anticancer therapy that did not include anti-EGFR monoclonal antibodies or irinotecan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a life expectancy of at least 3 months, and the ability to cooperate with efficacy and safety assessments.
Key exclusion criteria (13 listed)
- Pathologically confirmed intestinal tumors other than colon cancer, such as gastrointestinal stromal tumors.
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- History of or concurrent malignancies other than colon cancer, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma.
- Active autoimmune disease or a history of autoimmune disorders, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. Exceptions include autoimmune hypothyroidism controlled with a stable dose of thyroid hormone replacement therapy, type 1 diabetes mellitus controlled with a stable insulin regimen, vitiligo, or resolved childhood asthma/allergies requiring no intervention in adulthood.
- History of immunodeficiency, including positive human immunodeficiency virus (HIV) testing, acquired or congenital immunodeficiency disorders, organ transplantation, or allogeneic bone marrow transplantation.
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 |
|---|---|---|
| ToripalimabToripalimab 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. | Drug | Toripalimab + Cetuximab + Irinotecan |
| CetuximabCetuximab 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. | Drug | Toripalimab + Cetuximab + Irinotecan |
| IrinotecanIrinotecan 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. | Drug | Toripalimab + Cetuximab + Irinotecan |
Primary outcome
Objective Response Rate (ORR)
Time frame: From baseline until disease progression or initiation of new anticancer therapy, assessed up to approximately 24 months.
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.
5 secondary outcomes
Duration of Response (DoR)
Time frame: From the first documented CR or PR until disease progression or death, assessed up to approximately 24 months.
Disease Control Rate (DCR)
Time frame: From baseline until disease progression or initiation of new anticancer therapy, assessed up to approximately 24 months.
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until disease progression or death, assessed up to approximately 24 months.
Overall Survival (OS)
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)
Time frame: From the first dose of study treatment through 90 days after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- 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.
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 Toripalimab, Cetuximab and Irinotecan in people with Colorectal Cancer (CRC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 20 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongkun Sun ((+86)010-87788800, hsunyk@cicams.ac.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: From baseline until disease progression or initiation of new anticancer therapy, assessed up to approximately 24 months.). 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 27 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.