A Phase 2 interventional study of Ivarmacitinib Sulfate Tablets and Camrelizumab in Refractory Metastatic Colorectal Cancer, sponsored by Renmin Hospital of Wuhan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Renmin Hospital of Wuhan University · Phase 2, Interventional, and Treatment
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells.
To address this challenge, the investigators propose an innovative combination strategy aimed at remodeling the TME and alleviating immunosuppression. The investigators hypothesize that ivarmacitinib, a highly selective JAK1 inhibitor, may attenuate the immunosuppressive TME through modulation of JAK/STAT signaling, potentially converting "cold" tumors into "hot" tumors and enhancing the antitumor activity of camrelizumab, a PD-1 inhibitor, in combination with fruquintinib, a tyrosine kinase inhibitor (TKI). Accordingly, a single-arm, single-center, exploratory phase II clinical study was designed to enroll 33 patients with mCRC who have failed multiple lines of prior therapy. The study aims to evaluate the ORR, survival outcomes, and safety of this combination regimen. The findings are expected to provide preliminary evidence for a potential new therapeutic approach for this heavily pretreated patient population and establish a foundation for subsequent larger confirmatory studies.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 33 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Renmin Hospital of Wuhan University is the lead sponsor of 86 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 28, 2026. See what changed
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.
Exclusion Criteria:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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 New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
Drug: Ivarmacitinib Sulfate Tablets · Drug: Camrelizumab · Drug: Fruquintinib
Ivarmacitinib will be administered orally at a dose of 4 mg once daily for 2 weeks during the lead-in phase. During the combination induction phase, treatment will continue at 4 mg orally once daily. Ivarmacitinib will be discontinued after completion of the combination induction phase, unless earlier discontinuation is required.
Camrelizumab will be administered intravenously at a dose of 200 mg once every 3 weeks during the combination induction phase and the maintenance phase. During the maintenance phase, camrelizumab will be administered for 15 cycles. Treatment will be discontinued upon completion of the planned treatment period, disease progression, unacceptable toxicity, or fulfillment of another protocol-defined discontinuation criterion.
Fruquintinib will be administered orally at a dose of 5 mg once daily for 14 consecutive days, followed by 7 days off treatment, constituting a 21-day cycle. This regimen will be administered during the combination induction phase and the maintenance phase. Treatment will be discontinued upon completion of the planned treatment period, disease progression, unacceptable toxicity, or fulfillment of another protocol-defined discontinuation criterion.
PFS
Progression-free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression, as assessed according to RECIST version 1.1, or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method.
Time frame: From the first dose of study treatment through study completion, an average of 1 year
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Baseline through study completion, an average of 1 year
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
Time frame: Baseline through study completion, an average of 1 year
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 ↗
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Studies of the drugs tested here: Ivarmacitinib · Camrelizumab · HMPL-013
Renmin Hospital of Wuhan University