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Colorectal CancerPhase 2NCT05435313

Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Therapy

A Phase 2 study testing HAIC, Fruquintinib and Tislelizumab in people with Colorectal Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of fruquintinib combined with tislelizumab and HAIC (hepatic arterial infusion chemotherapy) in patients with colorectal liver metastases cancer (CRLM) who failed standard therapy. 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?
HAIC, Fruquintinib and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
12 Jul 2022to Feb 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent has been signed
  • Histologically or cytologically confirmed unresectable advanced colorectal liver metastases cancer
  • Age ≥ 18 years, ≤75 years
  • 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 have previously failed standard treatment, or who cannot tolerate standard treatment
  • Patients must have adequate organ and bone marrow function
  • Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration

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
  • 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.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200062

Other trials in China

About this study

Official title: A Single-center, Single-arm, Open-label Clinical Study of Fruquintinib Combined With Tislelizumab and HAIC in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Therapy

This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of fruquintinib combined with tislelizumab and HAIC (hepatic arterial infusion chemotherapy) in patients with colorectal liver metastases cancer (CRLM) who failed standard therapy.

Read the detailed description

Liver is the most common metastatic site in patients with colorectal cancer (CRC) and the leading cause of death in patients. Surgery is the best way to cure CRLM, but few patients can receive surgery, and patients prone to recurrence after surgery. It is an urgent topic to choose an effective treatment method with less side effects for CRLM patients. HAIC is a unique and effective treatment option for CRLM patients. Fruquintinib is a small molecule angiogenesis inhibitor, and has been recommended for third-line treatment of metastatic colorectal cancer (mCRC). Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody, meanwhile, tislelizumab shows significant and durable antitumor activity in patients with CRC, and is well tolerated.

Being tested
HAIC, Fruquintinib, Tislelizumab, Raltitrexed, Oxaliplatin
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAICProcedure or surgery

    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.

  • FruquintinibDrug

    3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC

  • TislelizumabDrug

    200mg, ivgtt, d1, 21 days for a cycle

  • RaltitrexedDrug

    2 mg/m2, hepatic artery infusion for 15 min, d1, 4-6 Cycles

  • OxaliplatinDrug

    85 mg/m2, hepatic artery infusion for 2 h, d1, 4-6 Cycles

  • IrinotecanDrug

    120mg/m2, hepatic artery perfusion for 30-90min, d1, 4-6 Cycles

Study groups in NCT05435313
Study groupRoleWhat they receive
combination therapyExperimentalCombination: Fruquintinib plus Tislelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Tislelizumab
Receives: Procedure: HAIC; Drug: Fruquintinib; Drug: Tislelizumab; Drug: Raltitrexed; Drug: Oxaliplatin; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. overall survival (OS)

    OS is the time from enrollment to death due to any cause.

    Measured: 24 months

  5. 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.

  1. First posted28 Jun 2022
  2. Study start12 Jul 2022
  3. Primary completionJan 2024 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

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
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435313
Sponsor's protocol ID
HMPL-013-FLAG-C122
Status last verified
Jan 2024
First submitted
23 Jun 2022
Last updated
17 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HAIC, Fruquintinib and Tislelizumab 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: status not confirmed, as of the sponsor's last update on 17 Jan 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT05435313.

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 17 Jan 2024.

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