Advanced Colorectal CarcinomaPhase 2NCT05406206
Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy
A Phase 2 study testing Fruquintinib and Hepatic Arterial Infusion Chemotherapy in people with Advanced Colorectal Carcinoma and Liver Metastasis Colon Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma, Liver Metastasis Colon Cancer
- What is being tested?
- Fruquintinib and Hepatic Arterial Infusion Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2022to 31 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female, age ≥ 18 years and ≤75, at the time of study entry.
- Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable).
- Previously received 2 lines of standard chemotherapy, including 5-FU, oxaliplatin, and irinotecan.
- Subjects must have at least one measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Estimated life expectancy of ≥12 weeks.
Show all 9Show fewer
- Adequate organ functions verified by laboratory tests within 7 days before the first intervention, including bone marrow, liver and kidney function, and coagulation function
- Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use an acceptable method of contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product.
- Written and signed informed consent.
Who cannot join
- ANC<1.5×10*9/L, PLT<80×10*9/L, or Hb<9g/dL; no blood infusion within 2 weeks.
- TBil>2.5 × ULN.
- AST or ALT>5 × ULN.
- Serum Cr>1.5 × ULN, or CrCl<50 ml/min (calculated by Cockcroft-Gault equation)
- APTT or PT> 1.5 × ULN.
- Clinically significant electrolyte abnormalities determined by investigators.
Show all 20Show fewer
- Proteinuria ≥ 2+ (1.0g/24hr).
- Hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg
- Active gastrointestinal ulceration, ulcerative colitis, or gastrointestinal bleeding; potential gastrointestinal bleeding or perforation determined by investigators.
- History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment; evidence of hemorrhagic tendency or receiving anticoagulant therapy within 2 months before enrollment.
- Stroke or transient cerebral ischemia occurred within 12 months before enrollment.
- History of cardiovascular disease within 6 months before enrollment, including congestive heart failure (NYHA grade>2), acute myocardial ischemia, severe/unstable angina or CABG; or LVEF<50%.
- Uncontrollable malignant ascites, pleural effusion, or pericardial effusion (determined by investigators).
- Previous treated with VEGFR inhibitors.
- Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ.
- Evidence of CNS metastasis.
- Active infection, such as acute pneumonia, active stage of HBV/HCV.
- Pregnant or lactating women.
- By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
- Severe mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xu Zhu, Master, 0086-10-88196330, drzhuxu@163.xom
Xu Zhu, Master
About this study
Official title: A Phase II Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Fruquintinib as Third-line Therapy for Patients With Unresectable Colorectal Cancer Liver Metastases
Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Combined with hepatic arterial infusion chemotherapy (HAIC), this study is conducted to assess the efficacy and safety of this regimen in patients with unresectable colorectal cancer liver metastases as the third-line therapy.
Read the detailed description
This will be a single-arm, open-label, phase II study. This study will be divided into 2 stages: dose exploration and dose expansion. In the dose exploration stage, "3+3 dose escalation" design will be applied to determined the maximum tolerated dose (MTD) of fruquintinib for next stage:
Cohort A: HAIC + fruquintinib 3mg QD, 3 weeks on/1 week off (3w/1w). Cohort B: HAIC + fruquintinib 4mg QD, 3w/1w. Cohort C: HAIC + fruquintinib 5mg QD, 3w/1w.
All subjects of this study will be permitted to continue therapy with only safety monitoring and assessments for progression, if the product is well tolerated and the subject has stable disease or better.
- Being tested
- Fruquintinib, Hepatic Arterial Infusion Chemotherapy
- Keywords
- Hepatic Arterial Infusion Chemotherapy, HAIC, Fruquintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called HMPL-013
Fruquintinib is a capsule in the form of 1mg and 5mg, once a day, 3 week on/1 week off.
Hepatic Arterial Infusion ChemotherapyProcedure or surgery
Also called HAIC
HAIC is a locoregional therapy for colorectal cancer liver metastasis. Oxaliplatin 85 mg/m*2 + 5-FU 2000 mg/m*2, Q4W
| Study group | Role | What they receive |
|---|---|---|
| HAIC combined with Fruquintinib | Experimental | HAIC with fruquintinib until progression. Fruquintinib should be administrated within 1 week after HAIC. Receives: Drug: Fruquintinib; Procedure: Hepatic Arterial Infusion Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Secondary outcomes (3)
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Measured: Up to 2 years
Duration of Response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Overall Survival (OS)
Overall survival is defined as the time from the start of treatment with HAIC until death due to any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start25 Feb 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Xu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406206
- Sponsor's protocol ID
- Fru-HAIC-01
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Fruquintinib as Third-line Therapy for Patients With Unresectable Colorectal Cancer Liver Metastases
- ClinicalTrials.gov ID
- NCT05406206
- Acronym / sponsor ID
- Fru-HAIC-01
- Keywords
- Hepatic Arterial Infusion Chemotherapy, HAIC, Fruquintinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 6 Jun 2022 (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.
Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Combined with hepatic arterial infusion chemotherapy (HAIC), this study is conducted to assess the efficacy and safety of this regimen in patients with unresectable colorectal cancer liver metastases as the third-line therapy.
Detailed description
This will be a single-arm, open-label, phase II study. This study will be divided into 2 stages: dose exploration and dose expansion. In the dose exploration stage, "3+3 dose escalation" design will be applied to determined the maximum tolerated dose (MTD) of fruquintinib for next stage:
Cohort A: HAIC + fruquintinib 3mg QD, 3 weeks on/1 week off (3w/1w). Cohort B: HAIC + fruquintinib 4mg QD, 3w/1w. Cohort C: HAIC + fruquintinib 5mg QD, 3w/1w.
All subjects of this study will be permitted to continue therapy with only safety monitoring and assessments for progression, if the product is well tolerated and the subject has stable disease or better.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC combined with Fruquintinib | Experimental | Drug: Fruquintinib, Procedure: Hepatic Arterial Infusion ChemotherapyHAIC with fruquintinib until progression. Fruquintinib should be administrated within 1 week after HAIC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age ≥ 18 years and ≤75, at the time of study entry.
- Histologically or cytologically documented advanced colorectal carcinoma with unresectable liver metastasis (existence of extrahepatic metastasis is acceptable).
- Previously received 2 lines of standard chemotherapy, including 5-FU, oxaliplatin, and irinotecan.
- Subjects must have at least one measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
Key exclusion criteria (20 listed)
- ANC<1.5×10*9/L, PLT<80×10*9/L, or Hb<9g/dL; no blood infusion within 2 weeks.
- TBil>2.5 × ULN.
- AST or ALT>5 × ULN.
- Serum Cr>1.5 × ULN, or CrCl<50 ml/min (calculated by Cockcroft-Gault equation)
- APTT or PT> 1.5 × ULN.
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 |
|---|---|---|
| FruquintinibAlso: HMPL-013Fruquintinib is a capsule in the form of 1mg and 5mg, once a day, 3 week on/1 week off. | Drug | HAIC combined with Fruquintinib |
| Hepatic Arterial Infusion ChemotherapyAlso: HAICHAIC is a locoregional therapy for colorectal cancer liver metastasis. Oxaliplatin 85 mg/m*2 + 5-FU 2000 mg/m*2, Q4W | Procedure or surgery | HAIC combined with Fruquintinib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Progression-free survival is defined as the time from the start of treatment HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Colorectal Carcinoma
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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. This study is not recruiting at the moment.
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 Fruquintinib and Hepatic Arterial Infusion Chemotherapy in people with Advanced Colorectal Carcinoma and Liver Metastasis Colon Cancer, run by Peking University Cancer Hospital & Institute 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 20 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Zhu, Master (+86-13501146178, drzhuxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 2 years). 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 6 Jun 2022.