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Colorectal Liver MetastasisPhase 2NCT05753163

Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Regorafenib as Adjuvant Therapy for Colorectal Liver Metastasis Patients With a High Risk of Recurrent: a Single-arm, Phase II Study

A Phase 2 study testing HAIC-FOLFOX combined with Sintilimab and Regorafenib in people with Colorectal Liver Metastasis, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Pts with histologically confirmed CRLM and whose CRS >2 were enrolled into this single-arm, phase II study. The critical enrollment criteria were that Subjects had completely resected Primary lesion and liver metastases and had no evidence of extrahepatic disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Liver Metastasis
What is being tested?
HAIC-FOLFOX combined with Sintilimab and Regorafenib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
2 Aug 2022to 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

  • Aged over 18 years， men or women who are not pregnant；
  • ECOG PS 0/1 evaluated 14 days before enrollment, and expected survival >12 months after liver resection;
  • Liver function: Child-Pugh score Class A or ≤7 Class B；
  • Patients with histologically- or clinically-confirmed CRLM（TxNxM1）and CRS>2；
  • Patients had completely resected Primary lesions and liver metastases as well as no evidence of extrahepatic disease；
  • No complications such as bleeding, jaundice, infection, abdominal pleural effusion, obstruction and perforation were observed within 7 days (including 7 days) before the screening. The subjects recovered well after surgery, the surgical incision healed well, the stitches were removed, and the drainage tube was removed;
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  • Preoperative chemoradiotherapy was limited to neoadjuvant or conversion therapy；
  • Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study；
  • Patients were considered capable of complying with the study protocol；
  • No medical comorbidities that could interfere with chemotherapy and immunotherapy or targeted therapy, see exclusion criteria；
  • Pre-treatment tumour tissue sample (if available). If tumour tissue is available, submit one formalin-fixed, paraffin-embedded (FFPE) tumour sample from a paraffin block (preferred), or approximately 10-15 slides containing unstained, freshly cut, serial sections, along with a relevant pathology report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples, cell mass samples [e.g., samples from pleural effusion] and lavage samples) may also be accepted. An associated pathology report should be provided with the sample. If tumour tissue is not available (e.g., exhausted due to past diagnostic tests), subjects are still eligible for study participation;
  • Adequate haematological and organ function， based on the following laboratory results obtained during the 14 days prior to enrollment (unless otherwise stated) ： Absolute neutrophil count (ANC)≥1.5×10 9 /L (1500/μL)， without supported granulocyte colony-stimulating factor Lymphocyte count ≥0.5×10 9 /L (500/μL) Platelets ≥ 75 × 10 9 /L（75, 000/μL） Haemoglobin≥ 85 g/L, blood transfusions may be permitted to meet this criterion Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 5 × upper limit of normal (ULN); Serum bilirubin≤ 3 × ULN Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥50 mL/min (using Cockcroft-Gault formula) Serum albumin≥28 g/L（2.8 g/dL） INR or aPTT≤2 × ULN, or PT prolonged ≤ 3 s if patients did not receive anticoagulant therapy.
  • Albuminuria < 2+ tested by urinary cellulose (carried out within 14 days prior to initiation of treatment); Patients with baseline albuminuria ≥2+ should have their urine collected for 24 hours and must then confirm that albuminuria content within 24 hours is < 1g.
  • Any acute, clinically significant treatment-related toxicity (due to prior treatment) must have resolved to ≤ grade 1 prior to enrollment, except for hair loss;
  • HIV antibody test results were negative at screening;
  • Patients with active hepatitis B virus (HBV) infection: HBVDNA < 2000IU/mL acquired within 28 days prior to enrollment, receiving anti-HBV therapy (in accordance with local standard care, such as Entecavir) for at least 7 days prior to enrollment and willing to continue treatment during the study period; Patients with active hepatitis C virus (HCV) infection: HCVRNA < 2000IU/mL acquired within 28 days prior to enrollment, receiving anti-HCV therapy for at least 7 days prior to enrollment and willing to continue treatment during the study;
  • Women of childbearing age must undergo a negative pregnancy test (βHCG) before treatment, and women of childbearing age and men (who have sex with women of childbearing age) must agree to use effective contraception uninterrupted during treatment and for six months after the last therapeutic dose was administered.

Who cannot join

  • Colorectal cancer with extrahepatic metastasis;
  • Malignant abdominal effusion;
  • There were postoperative complications such as abdominal effusion, pleural effusion, intestinal cavity perforation, bleeding and intestinal obstruction that needed treatment.
  • History of soft meningitis
  • Current or past autoimmune diseases or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: Subjects who had a history of autoimmune-related hypothyroidism and were receiving thyroid hormone replacement therapy were eligible; Subjects with controlled type 1 diabetes receiving insulin therapy were eligible; Subjects with clinical manifestations of eczema, psoriasis, chronic lichenia simple, or vitiligo only (e.g., excluding subjects with psoriatic arthritis) are eligible if they meet all of the following criteria: 1. Skin rash area must be < 10% body surface area 2. Good disease control at baseline with only inefficient topical glucocorticoid therapy. 3. No acute exacerbations requiring psoralen plus A-band ultraviolet radiation, methotrexate, retinoic acid, biologics, oral calcineurin inhibitors, or high-performance or oral glucocorticoid therapy have occurred in the previous 12 months;
  • Idiopathic pulmonary fibrosis, institutionalized pneumonia (e.g., bronchiolitis obliterans), drug-induced or idiopathic pneumonia, or evidence of active pneumonia on a chest computed tomography (CT) scan during screening. Radiation pneumonia was present in the allowable area (fibrosis)
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  • Active TB disease
  • Major cardiovascular disease (such as New York Heart Society Class II or worse heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina in the 3 months prior to enrollment;
  • A history of congenital long QT syndrome or a corrected QT interval >500ms at screening (calculated using Fridericia's method);
  • A history of uncorrected electrolyte disturbances such as serum potassium, calcium, or magnesium
  • Received major surgery within 4 weeks prior to the enrollment (except for diagnosis) or expected to require major surgery during the study period;
  • Malignancies other than CRC that have developed within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, duct carcinoma in situ, or stage I uterine cancer;
  • Severe infections, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications, occurred in the 4 weeks prior to the enrollment;
  • Therapeutic antibiotics were given orally or intravenously within 2 weeks prior to the enrollment. Subjects who received prophylactic antibiotics (for example, to prevent urinary tract infections or exacerbations of COPD) were eligible;
  • Previous allogeneic stem cell or solid organ transplantation;
  • Received live attenuated vaccine within 4 weeks prior to the enrollment, or expected to receive such vaccine during sintilimab treatment or within 5 months after the last dose;
  • With untreated or incompletely treated esophageal and/or gastric varicose veins associated with bleeding or at high risk of bleeding. Prior to enrollment, subjects must undergo ultrasound, CT, MRI, or liver elasticity tests, assess the size of all varicose veins (small to large), and be treated according to local standard care. Subjects who received the corresponding examination within 6 months prior to the enrollment do not need to be re-examined;
  • Co-infection with HBV and HCV. Subjects with a history of HCV infection but negative PCR results for HCV RNA are considered not infected with HCV;
  • Symptomatic, untreated, or progressive central nervous system (CNS) metastases. Asymptomatic subjects whose CNS lesions have been treated are eligible as long as they meet all of the following criteria: They must have measurable lesions outside the CNS according to RECIST v1.1; Subjects had no history of intracranial or spinal bleeding; Metastases are limited to the cerebellar or supratentorial regions (i.e., no midbrain, pontine, medullary, or spinal cord metastases); No evidence of progress between completion of CNS oriented therapy and initiation of study therapy; Subjects had not received stereotactic, whole brain radiation, and/or neurosurgical resection within 28 days prior to the enrollment; There was no need for continuous use of glucocorticoids to treat CNS disease. A steady dose of anticonvulsant therapy is permitted. Asymptomatic subjects with newly detected CNS metastases at the time of screening are eligible after radiotherapy or surgery, and no need for repeated screening of brain scan results;
  • Refuse follow-up and participating in other clinical trials that may interfere with this study;
  • Patients are not suitable for enrollment judged by investigators.

Trial locations and contacts

1 site in 1 country.

Lu Wang, M.D. contact

+86-18121299357

sysucczyf@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Lu Wang, +8618121299357, w.lr@hotmail.com

    Recruiting

Other trials in China

About this study

Pts with histologically confirmed CRLM and whose CRS >2 were enrolled into this single-arm, phase II study. The critical enrollment criteria were that Subjects had completely resected Primary lesion and liver metastases and had no evidence of extrahepatic disease. After hepatectomy， HAIC (FOLFOX: oxaliplatin 85mg/m2, 5- fluorouracil 2500mg/m2, calcium folinate 400mg/m2) was given every 4-6 weeks for 2-4 cycles depending on pts' health status, in combination with Sintilimab (200mg, iv, d1) and regorafenib (80mg, po, d1-21) every 3 weeks for up to 6 months. The primary endpoint was 1-year recurrence-free survival (RFS) and secondary endpoints included RFS, overall survival (OS), safety, and health-related quality of life.

Being tested
HAIC-FOLFOX combined with Sintilimab and Regorafenib

What participants receive

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

  • HAIC-FOLFOX combined with Sintilimab and RegorafenibCombination product

    HAIC (FOLFOX: oxaliplatin 85mg/m2, 5- fluorouracil 2500mg/m2, calcium folinate 400mg/m2) was given every 4-6 weeks for 2-4 cycles depending on pts' health status, in combination with Sintilimab (200mg, iv, d1) and regorafenib (80mg, po, d1-21) every 3 weeks for up to 6 months .

Study groups in NCT05753163
Study groupRoleWhat they receive
treatmentExperimentalNot described
Receives: Combination Product: HAIC-FOLFOX combined with Sintilimab and Regorafenib

What is being measured

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

  1. 1-year recurrence-free survival rate (1-year RFS)

    Incidence of recurrence-free patients in one year

    Measured: 12 months

Secondary outcomes (4)

  1. recurrence-free survival (RFS)

    time from surgery to recurrence or death

    Measured: Up to approximately 2 years

  2. overall survival (OS)

    time from enrollment to death

    Measured: Up to approximately 5 years

  3. Safety and tolerability

    adverse effect，Incidence of Adverse Events and Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: Up to approximately 2 years

  4. health-related quality of life (HRQol)

    using patient-reported outcomes(PROs) via The European Organisation for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30)

    Measured: Up to approximately 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 posted3 Mar 2023
  2. Study start2 Aug 2022
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753163
Sponsor's protocol ID
2022-GWK-001
Status last verified
Mar 2023
First submitted
21 Feb 2023
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HAIC-FOLFOX combined with Sintilimab and Regorafenib in people with Colorectal Liver Metastasis, 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 17 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 3 Mar 2023. 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 Lu Wang, M.D. (+86-18121299357, sysucczyf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year recurrence-free survival rate (1-year RFS) (time frame: 12 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 NCT05753163.

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 3 Mar 2023.

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