Colorectal CancerPhase 2NCT06423937
Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer
A Phase 2 study testing combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab in people with Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
Liver metastasis is the main cause of death in patients with colorectal cancer. The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- May 2024to Jul 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects volunteered to join the study and signed informed consent, with good compliance and follow-up.
- Patients with histologically or cytologically confirmed non-MSI-H ( according to the detection criteria of the institutional testing center, immunohistochemistry, PCR or NGS detection can be used ) unresectable advanced colorectal cancer with liver metastasis ;
- Age ≥ 18 years, ≤75 years， male or female ;
- ECOG PS 0-1;
- Expected overall survival ≥3 months
- Patients must have at least one measurable liver metastases (RECIST 1.1)
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- Patients who had only received one standard first-line systemic treatment and were confirmed to be ineffective, or could not tolerate first-line treatment ;
- Patients must have adequate organ and bone marrow function( No blood components and cell growth factors were used within 14 days before enrollment )
- Male or female patients with fertility voluntarily used effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of treatment in the last study. All female patients will be considered to have fertility, unless the female patient has natural menopause, artificial menopause or sterilization ( such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation, etc. ), otherwise the female patient 's serum or urine test showed no pregnancy within 7 days before the study, and must be non-lactating patients.
Who cannot join
- Patients who are allergic or suspected to be allergic to the study drug or similar drugs
- Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
- Participating in other clinical trials and received at least one treatment within 4 weeks before enrollment
- Patients with autoimmune disease or history of autoimmune disease within 4 weeks before enrollment
- patients currently have central nervous system (CNS) metastasis or previous brain metastasis and the symptom control time is less than 2 months
- Patients cannot take fruquintinib orally
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- Patients who have received organ transplantation and bone marrow transplantation in the past
- Have taken other strong inducers or inhibitors of CYP3A4, P-gp substrates and BCRP substrates within 2 weeks before the First medication
- Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment
- Pleural effusion or ascites causing relevant clinical symptoms, including respiratory syndrome (dyspnea≥CTC AE grade 2)
- Clinically significant electrolyte abnormality#
- Systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs
- Proteinuria ≥ 2+ (1.0g/24hr);
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator;
- Have evidence or history of bleeding tendency within 3 months or thromboembolic events within 12 months before enrollment( Hemorrhage > 30 mL within 3 months, hematemesis, black feces, hematochezia ), hemoptysis ( fresh blood > 5 mL within 4 weeks ) or thromboembolic events ( including stroke events and / or transient ischemic attack ) within 12 months ;
- Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification > 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval ≥ 480 ms
- Active or uncontrolled serious infection (≥CTCAE grade 2 infection)
- Pregnant or lactating women
- Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of investigator that the patient is not suitable for the the study drug (such as having epileptic seizures and require treatment), or would affect the interpretation of study results, or put patients at high risk
- Clinical uncontrolled active infections, including human immunodeficiency virus (HIV) infection, active hepatitis B / C (HBV DNA Positive[1×104 copies/mL or >2000 IU/ml], HCV RNA positive[>1×103 copies/mL]);
- Patients have other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental diseases) that require concomitant treatment, and serious laboratory abnormalities. Accompanied by family or social factors, which will affect the safety of patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-center, Open-label, Double-cohort Clinical Study of Fruquintinib Plus Camrelizumab Plus HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer Patients With Liver Metastasis After the Failure of First-line Treatment
Liver metastasis is the main cause of death in patients with colorectal cancer. The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients. The purpose of this study was to investigate the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC regimen in the treatment of non-MSI-H advanced colorectal cancer patients with liver metastasis after first-line standard treatment failure. Compared with the current standard second-line treatment plan, it provides new decisions for clinical practice, in order to reduce the adverse reactions of treatment and improve the tolerance and efficacy of patients. To provide more and more optimized medication options for patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis.
Read the detailed description
This is a single-center, open, double-cohort clinical study to explore the non-MSI-H type advanced colorectal cancer patients with liver metastases after the failure of first-line standard treatment with fruquintinib combined with calelizumab and HAIC.Clinically, systemic chemotherapy with 5-FU as the core, combined with irinotecan or oxaliplatin is the first-line and second-line standard chemotherapy regimen for unresectable CRLM patients, but various hepatotoxicity will occur during chemotherapy. HAIC can selectively deliver chemotherapeutic drugs to tumor cells, reduce hepatocyte toxicity, relatively preserve liver parenchyma, and increase the concentration of chemotherapy in the tumor. Tumor cells are exposed to chemotherapy for a longer time, which effectively improves the efficacy and safety of treatment. Anti-angiogenic drugs can hinder the growth of microvessels in tumors and the development of metastatic diseases. At present, multiple retrospective studies have provided evidence support. The response rate of HAIC combined with systemic targeted therapy can reach 74 % -92 %. Previous studies have suggested that anti-angiogenic drugs combined with immunotherapy is expected to be a treatment strategy for patients with advanced colorectal cancer who fail to receive standard treatment or cannot receive standard treatment. Therefore, this study investigated the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC in the treatment of patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis after first-line standard treatment failure.
- Conditions
- Colorectal Cancer
- Being tested
- combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus CamrelizumabDrug
Procedure/Surgery: HAIC After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs.
TOMOX（Raltitrexed 2 mg/m2, Oxaliplatin 85mg/m2）/ TOMIRI（Raltitrexed 2 mg/m2 ，Irinotecan 120mg/m2） Drug: Fruquintinib 3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC Drug: Camrelizumab 200mg, ivgtt,, 21 days for a cycle
| Study group | Role | What they receive |
|---|---|---|
| Advanced non-MSI-H left-sided colorectal cancer | Experimental | Advanced non-MSI-H left-sided colorectal cancer with liver metastasis after first-line standard treatment failure Receives: Drug: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab |
| Advanced non-MSI-H right-sided colorectal cancer | Experimental | Advanced non-MSI-H right-sided colorectal cancer with liver metastasis after first-line standard treatment failure Receives: Drug: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: 24 months
Secondary outcomes (5)
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response#CR# or partial response#PR# or stable disease#SD# per RECIST 1.1 as assessed by investigator
Measured: 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: 24 months
Progression-Free Survival rate at 6 months
The proportion of patients who did not experience disease progression or death from treatment initiation to 6 months
Measured: 6 months
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: 24 months
Adverse events as assessed by NCI CTCAE v5.0
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study startMay 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423937
- Sponsor's protocol ID
- HMPL-013-SH-CRC-106
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Double-cohort Clinical Study of Fruquintinib Plus Camrelizumab Plus HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer Patients With Liver Metastasis After the Failure of First-line Treatment
- ClinicalTrials.gov ID
- NCT06423937
- Acronym / sponsor ID
- HMPL-013-SH-CRC-106
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 May 2024 (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.
Liver metastasis is the main cause of death in patients with colorectal cancer. The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients. The purpose of this study was to investigate the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC regimen in the treatment of non-MSI-H advanced colorectal cancer patients with liver metastasis after first-line standard treatment failure. Compared with the current standard second-line treatment plan, it provides new decisions for clinical practice, in order to reduce the adverse reactions of treatment and improve the tolerance and efficacy of patients. To provide more and more optimized medication options for patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis.
Detailed description
This is a single-center, open, double-cohort clinical study to explore the non-MSI-H type advanced colorectal cancer patients with liver metastases after the failure of first-line standard treatment with fruquintinib combined with calelizumab and HAIC.Clinically, systemic chemotherapy with 5-FU as the core, combined with irinotecan or oxaliplatin is the first-line and second-line standard chemotherapy regimen for unresectable CRLM patients, but various hepatotoxicity will occur during chemotherapy. HAIC can selectively deliver chemotherapeutic drugs to tumor cells, reduce hepatocyte toxicity, relatively preserve liver parenchyma, and increase the concentration of chemotherapy in the tumor. Tumor cells are exposed to chemotherapy for a longer time, which effectively improves the efficacy and safety of treatment. Anti-angiogenic drugs can hinder the growth of microvessels in tumors and the development of metastatic diseases. At present, multiple retrospective studies have provided evidence support. The response rate of HAIC combined with systemic targeted therapy can reach 74 % -92 %. Previous studies have suggested that anti-angiogenic drugs combined with immunotherapy is expected to be a treatment strategy for patients with advanced colorectal cancer who fail to receive standard treatment or cannot receive standard treatment. Therefore, this study investigated the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC in the treatment of patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis after first-line standard treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced non-MSI-H left-sided colorectal cancer | Experimental | Drug: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus CamrelizumabAdvanced non-MSI-H left-sided colorectal cancer with liver metastasis after first-line standard treatment failure |
| Advanced non-MSI-H right-sided colorectal cancer | Experimental | Drug: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus CamrelizumabAdvanced non-MSI-H right-sided colorectal cancer with liver metastasis after first-line standard treatment failure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subjects volunteered to join the study and signed informed consent, with good compliance and follow-up.
- Patients with histologically or cytologically confirmed non-MSI-H ( according to the detection criteria of the institutional testing center, immunohistochemistry, PCR or NGS detection can be used ) unresectable advanced colorectal cancer with liver metastasis ;
- Age ≥ 18 years, ≤75 years， male or female ;
- ECOG PS 0-1;
- Expected overall survival ≥3 months
Key exclusion criteria (21 listed)
- Patients who are allergic or suspected to be allergic to the study drug or similar drugs
- Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
- Participating in other clinical trials and received at least one treatment within 4 weeks before enrollment
- Patients with autoimmune disease or history of autoimmune disease within 4 weeks before enrollment
- patients currently have central nervous system (CNS) metastasis or previous brain metastasis and the symptom control time is less than 2 months
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 |
|---|---|---|
| combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus CamrelizumabProcedure/Surgery: HAIC After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs. TOMOX（Raltitrexed 2 mg/m2, Oxaliplatin 85mg/m2）/ TOMIRI（Raltitrexed 2 mg/m2 ，Irinotecan 120mg/m2） Drug: Fruquintinib 3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC Drug: Camrelizumab 200mg, ivgtt,, 21 days for a cycle | Drug | Advanced non-MSI-H left-sided colorectal cancer, Advanced non-MSI-H right-sided colorectal cancer |
Primary outcome
objective response rate (ORR)
Time frame: 24 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
5 secondary outcomes
disease control rate (DCR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Progression-Free Survival rate at 6 months
Time frame: 6 months
overall survival (OS)
Time frame: 24 months
Adverse events as assessed by NCI CTCAE v5.0
Time frame: 24 months
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 21 May 2024.
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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 combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab in people with Colorectal Cancer, run by Fudan University 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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 21 May 2024. 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 Tan Li (158 0068 0751, 121176421@qq.com), 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: 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 21 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.