AzTrials
AzTrials

Colorectal CancerPhase 2NCT05524155

Sintilimab Combined With Regorafenib and HAIC in Patients With Colorectal Liver Metastasis

A Phase 2 study testing HAIC, Sintilimab and Regorafenib in people with Colorectal Cancer and Liver Metastasis, run by Tianjin Medical University Cancer Institute and Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

To evaluate the safety and efficacy of sintilimab combined with regorafenib and HAIC in patients with colorectal liver metastasis who failed second-line therapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Liver Metastasis
What is being tested?
HAIC, Sintilimab and Regorafenib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Sep 2022to Dec 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

  • Sign written informed consent before performing any trial related procedures
  • ≥ 18 years old
  • Histologically or cytologically proven unresectable metastatic colorectal cancer with liver metastases (AJCC 8th IV)
  • Intolerance to second-line therapy, or disease progression during or after second-line therapy (RECIST V1.1)
  • At least one radiographically measurable lesion, according to the RECIST V1.1 criteria
  • Patients with asymptomatic brain metastases or stable symptoms after local treatment were allowed to enroll if they met the following criteria:
Show all 23Show fewer
  • Measurable lesions outside the central nervous system
  • No central nervous system symptoms, or symptoms not worsened for at least 2 weeks
  • No glucocorticoid therapy was required or glucocorticoid therapy was discontinued within 7 days before the first study drug administration
  • Palliative radiation therapy (including craniocerebral radiation for symptomatic brain metastases) was permitted, provided that the radiation had ended at least 1 week before enrollment and that the radiotherapy-related toxicity had recovered to grade 1 or less (CTCAE 5.0, except alopecia).
  • ECOG PS scores 0-1
  • The expected survival time was >3 months
  • Sufficient organ functions, the subjects need to meet the following laboratory indicators:
  • ANC ≥1.5×10^9/L without the use of granulocyte colony-stimulating factor in the last 14 days
  • Platelets ≥90×10^9/ without blood transfusion in the past 14 days
  • Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days
  • Total bilirubin ≤1.5× upper limit of normal (ULN); Or total bilirubin >ULN but direct bilirubin ≤ ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in ≤2.5×ULN (ALT or AST ≤5×ULN allowed in patients with liver metastases)
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥ 60 ml/min
  • Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN
  • Normal thyroid function, defined as thyroid stimulating hormone (TSH) within normal limits. If the baseline TSH was outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range could also be enrolled
  • The myocardial zymogram is within the normal range (if the investigator comprehensively determines that the simple laboratory abnormality is not of clinical significance, it is also allowed to be enrolled)
  • Pregnancy test negative and use birth control

Who cannot join

  • Previous treatment with regorafenib
  • Previous treatment with anti-PD-L1, anti-PD-L2 drugs, or other drugs that stimulates or synergistically inhibits T-cell receptors (e.g., CTLA-4, OX-40, CD137)
  • Symptomatic or high risk of obstruction, bleeding, perforation, pneumonia (including noncommunicable pneumonia with previous hormonal therapy and pneumonia in patients receiving treatment)
  • Malignancy other than colorectal cancer diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or carcinoma in situ after radical resection)
  • currently participating in an interventional clinical study treatment, or has received another study drug or used a study device within 4 weeks prior to the first dose
  • Systemic systemic therapy with proprietary Chinese medicine or immunomodulatory agents (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) with anti-tumor indications was received within 2 weeks before the first dose
Show all 22Show fewer
  • Active autoimmune disease requiring systemic therapy occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy
  • Receiving systemic glucocorticoid therapy (excluding intranasal, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose; Physiological doses of glucocorticoids (≤10 mg/day or equivalent prednisone) are permitted
  • Blood transfusion within 7 days before the first dose
  • Clinically uncontrollable pleural effusion/abdominal effusion
  • Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation
  • Known allergy to the active ingredient or excipient of the study drug
  • Not fully recovered from toxicity and/or complications caused by any intervention (≤ grade 1 or baseline, excluding fatigue or alopecia) before starting treatment
  • HIV 1/2 antibody positive
  • Untreated active hepatitis B, subjects who met the following criteria could also be enrolled:
  • HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy to avoid virus reactivation throughout the study
  • Subjects with anti-HBC (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) did not require prophylactic anti-HBV therapy, but did require close monitoring for viral reactivation
  • Active HCV-infected
  • Received live vaccine within 30 days prior to the first dose，Inactivated virus vaccines for injectable use against seasonal influenza are permitted up to 30 days before the first dose，live attenuated influenza vaccines administered intranasally not allowed
  • Pregnant or lactating woman
  • With any severe or uncontrolled systemic disease
  • Other conditions that the subjects are not suitable to participate in this study according to the judgment of the investigator

Trial locations and contacts

No sites are listed yet.

Tongguo Si contact

18526812877

18526812877@163.com

About this study

Official title: Safety and Efficacy of Sintilimab Combined With Regorafenib and HAIC in Patients With Colorectal Liver Metastasis Who Failed Second-line Therapy

To evaluate the safety and efficacy of sintilimab combined with regorafenib and HAIC in patients with colorectal liver metastasis who failed second-line therapy

Being tested
HAIC, Sintilimab, Regorafenib
Keywords
Colorectal Liver Metastasis, Sintilimab, Regorafenib, HAIC
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • HAICDrug

    Also called Hepatic Artery Infusion Chemotherapy

    hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

  • SintilimabDrug

    Also called IBI308

    200mg IV d1,Q3W

  • RegorafenibDrug

    80mg/day,PO,QD,d1～21,Q4W

Study groups in NCT05524155
Study groupRoleWhat they receive
Sintilimab Combined With Regorafenib and HAICExperimentalSintilimab Combined With Regorafenib and HAIC
Receives: Drug: HAIC; Drug: Sintilimab; Drug: Regorafenib

What is being measured

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

  1. Adverse Events (AEs)

    Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

    Measured: up to 24 months

  2. Overall response rate ( ORR)

    Defined as proportion of patients who have a best response of CR or PR

    Measured: up to 24 months

Secondary outcomes (4)

  1. Disease control rate (DCR)

    Defined as proportion of patients who have a best response of CR, PR or SD

    Measured: up to 24 months

  2. Duration of response (DoR)

    Defined as the time from first confirmed response (CR or PR) to the date of the first documented tumor progression or death due to any cause, whichever occurs first.

    Measured: up to 24 months

  3. Progression free survival (PFS)

    Defined as the time from enrollment to disease progression or death, whichever occurs first

    Measured: up to 28 months

  4. Overall survival (OS)

    Defined as the time from the date of treatment start to the date of death

    Measured: up to 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionDec 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524155
Sponsor's protocol ID
SRHCL
Status last verified
Aug 2022
First submitted
26 Aug 2022
Last updated
1 Sep 2022
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, Sintilimab and Regorafenib in people with Colorectal Cancer and Liver Metastasis, run by Tianjin Medical University Cancer Institute and Hospital.

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 23 inclusion and 22 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Tongguo Si (18526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 NCT05524155.

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 1 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in