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Colorectal Liver MetastasesPhase 2NCT05877001

The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases

A Phase 2 study testing Tislelizumab, Regorafenib and HAIC in people with Colorectal Liver Metastases, run by Peking University Cancer Hospital & Institute at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Liver Metastases
What is being tested?
Tislelizumab, Regorafenib and HAIC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
30 May 2023to 1 Mar 2025
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

  • Age≥18 years old
  • Histologically or cytologically confirmed colorectal cancer with unresectable or surgical contraindicated liver metastases
  • Extrahepatic metastases are allowed and the primary tumor load is assessed to be intrahepatic by two or more attending physicians
  • Whether liver metastases can be resected or not is determined by two or more attending physicians according to the Chinese guidelines for the diagnosis and comprehensive treatment of colorectal liver metastases
  • Patients with unresectable colorectal liver metastases after failed standard second-line therapy
  • Including, but not limited to, Oxaliplatin, Fluorouracil, and Irinotecan
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  • Treatment failure is defined as disease progression and intolerable toxicity
  • Patients who withdrew from standard therapy due to unacceptable toxicity, guaranteed to discontinue treatment before disease progression and excluded treatment with the same drug, are also allowed to be included in the study.
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Subject life expectancy ≥12 weeks
  • Laboratory tests of bone marrow, hepatic and renal function and coagulation function within 7 days before the first dose of medication meet the study requirements
  • No blood transfusion, blood products, or correction with granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 7 days before laboratory testing.
  • Female patients of childbearing age must have a negative blood pregnancy test within 7 days before the first dose of medication and male or female patients of childbearing age volunteered to take effective contraceptive measures during the whole treatment and within 3 months after treatment
  • All patients must sign an informed consent form and follow the trial treatment protocol and follow up plan

Who cannot join

  • ANC <1.5×109/L, or platelet count <80×109/L, or HGB < 9g/dL;
  • Blood transfusion to meet enrollment criteria within 2 weeks before enrollment is not allowed
  • serum total bilirubin>2.0 times upper limit of normal
  • AST and/or ALT>5.0 times upper limit of normal
  • Serum creatinine>1.5 times upper limit of normal, or creatinine clearance rate<50ml/min(calculated according to the Cockcroft-Gault formula)
  • APTT or PT>1.5 times upper limit of normal
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  • Clinically significant severe electrolyte abnormalities by the investigator
  • Urine protein test 2+ or more, or 24 hours urine protein quantitation ≥1.0g/24h
  • Hypertension that is not stably controlled by medications: systolic blood pressure(SBP) >140mmHg or diastolic blood pressure(DBP) > 90mmHg
  • Patients with active gastric and duodenal ulcer, ulcerative colitis or other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigators; Or patients with previous gastrointestinal perforation or gastrointestinal fistula, which is not cured after surgical treatment
  • History of arterial or deep-vein thrombosis within 6 months before enrollment or evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity
  • History of troke or transient ischemic attack within 12 months before enrollment
  • History of heart disease within 6 months before enrollment, manifested as congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting; impaired cardiac function in NYHA class 2 or above; left ventricular ejection fraction (LVEF) <50%
  • Uncontrolled malignant pleural, ascites, or pericardial effusion
  • defined as not being effectively controlled with diuretics or punctures
  • Clinically detectable second primary malignancy or history of other malignancies within 5 years. Adequately treated nonmelanoma skin cancers, cervical carcinoma in situ, and superficial bladder tumors [noninvasive tumors, carcinoma in situ, and T1 (tumor invasion of the lamina propria)] are excluded
  • Central nervous system (CNS) metastases or previous brain metastases
  • Clinically uncontrolled severe active infection
  • Pregnant or lactating women or women of childbearing age have a positive pregnancy test before the first dose of medication; Or female participants themselves and their partners who are unwilling to use strict contraception during the trial
  • Patients are considered by the investigator to have any clinical or laboratory abnormalities or compliance issues that precluded participation in the trial
  • Serious psychological or psychiatric abnormalities

Trial locations and contacts

2 sites in 1 country.

Xu Zhu, MD contact

+86-10-88196001

drzhuxu@163.com

Feng Aiwei, MD contact

+86-10-88196330

ivyfeng_1026@163.com

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Zhu Xu, M.D., 0086-10-88196330, zhux387@263.net

    Aiwei Feng, M.D., 0086-10-88196330, ivyfeng_1026@163.com

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Xu Zhu, M.D., 861088196330, drzhuxu@163.com

    Aiwei Feng, M.D., 861088196330, ivyfeng_1026@163.com

    Recruiting

Other trials in China

About this study

Official title: An Open Label, Single-center Study on the Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib in Patients With Advanced Treated Colorectal Liver Metastases

Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases. NCCN guidelines and several expert consensus recommend that regional hepatic arterial infusion chemotherapy can be considered as a "rescue treatment" for patients with colorectal cancer liver metastases who fail to receive first-line or second-line systemic chemotherapy, which can significantly prolong the overall survival of patients.

Read the detailed description

The investigators aimed to evaluated the safety and efficacy of HAIC combined with Tislelizumab and Regorafenib in patients with advanced treated colorectal liver metastases. This study is a prospective, open label, single-center clinical study and the sample size is 20.

Being tested
Tislelizumab, Regorafenib, HAIC

What participants receive

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

  • TislelizumabDrug

    Also called BGB-A317

    200mg, IV, Q3W

  • RegorafenibDrug

    Also called BAY73-4506

    80 mg once daily for the first 3 weeks of each 4-week cycle

  • HAICOther

    OXA 85mg/m2 IA 0-4h +5-Fu 2000mg/m2 IA 4-48h，CF 200mg/m2 IV 2-4h， Q3W

Study groups in NCT05877001
Study groupRoleWhat they receive
HAIC combined with Tislelizumab and RegorafenibExperimentalHAIC combined with Tislelizumab and Regorafenib until progression or death.
Receives: Drug: Tislelizumab; Drug: Regorafenib; Other: HAIC

What is being measured

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

  1. Safety profiles by NCI-CTCAE version 5 .0

    The evaluation of adverse events , using NCI-CTCAE version 5.0.

    Measured: From the first patient enrolled to 15 months after the last patient enrolled.

Secondary outcomes (8)

  1. Overall 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

  2. Disease control rate(DCR)

    The ORR is defined as the proportion of subjects with confirmed complete response, partial response, or stable disease according to RECIST v 1.1.

    Measured: Up to 2 years

  3. Duration of Response (DoR)

    The time from the date of first documentation of a partial response or complete response to the date of first documentation of progressive disease (PD) or date of death due to any cause.

    Measured: Up to 2 years

  4. Response rate of intrahepatic lesions

    Response rate of intrahepatic lesions defined as the proportion of intrahepatic lesions that achieved complete response or partial response, regardless of extrahepatic lesions.

    Measured: Up to 2 years

  5. Response rate of extrahepatic lesions

    Response rate of extrahepatic lesions defined as the proportion of intrahepatic lesions that achieved complete response or partial response, regardless of intrahepatic lesions.

    Measured: Up to 2 years

  6. Quality of Life (QoL)

    The patient's ability to perform daily living can be evaluated through specific questionnaire(EORTC QLQ-C30), so as to evaluate the effect of anti-tumor drug treatment.

    Measured: Up to 2 years

  7. Overall survival (OS)

    Overall survival is defined as the time from the start of HAIC until death due to any cause.

    Measured: Up to 2 years

  8. Progression free survival (PFS)

    Progression-free survival is defined as the time from the start of HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first.

    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.

  1. First posted26 May 2023
  2. Study start30 May 2023 (estimated)
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion1 Mar 2025 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877001
Sponsor's protocol ID
2022KT98
Status last verified
Dec 2022
First submitted
17 Jan 2023
Last updated
26 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Regorafenib and HAIC in people with Colorectal Liver Metastases, run by Peking University Cancer Hospital & Institute at 2 sites 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 15 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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, MD (+86-10-88196001, drzhuxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profiles by NCI-CTCAE version 5 .0 (time frame: From the first patient enrolled to 15 months after the last patient enrolled.). 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 NCT05877001.

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 26 May 2023.

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