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Metastatic Colorectal CancerPhase 2NCT06231017

Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer

A Phase 2 study testing Adebrelimab + Cetuximab+ Chemotherapy in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital of Zhengzhou 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Adebrelimab + Cetuximab+ Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
19 Jan 2024to 19 Jan 2026
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

  • 1. Patients who have fully understood and voluntarily signed informed consent forms for this study, have good compliance, and cooperate with follow-up; 2. Age ≥ 18 years and ≤ 75 years old; 3. ECOG 0-1; 4. Expected survival time ≥ 12 weeks; 5. Patients confirmed by histology or pathology to have colon or rectal glands; 6. Primary or metastatic tumors of the colon are identified as RAS/BRAF wild-type; 7. PET/CT scan, CT scan, MRI or intraoperative exploration diagnosis (if applicable during resection of primary colorectal tumor), record evidence of limited liver metastasis in the patient (histological confirmation of liver metastasis is not required); 8. Primary colorectal cancer can be or has been radically resected, initial inability to R0 resection of liver metastases, or residual liver volume ≤ 30-40% after resection; 9. The patient has at least one measurable liver metastasis lesion (according to RECIST 1.1 standard); 10. There was no previous liver metastasis chemotherapy; 11. The main organ function is normal, which meets the following criteria:
  • Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):
  • Hemoglobin (Hb) ≥ 90 g/L; B. Neutrophil count (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 100 × 109/L;
  • Biochemical examination must meet the following standards:
  • Total bilirubin (TBIL)<1.5 upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 2.5 ULN, while for patients with liver metastasis, they are less than 5 ULN; C. Serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance rate>60ml/min (Cockcroft Gault formula); D. The urine routine test results show that urine protein (UPRO)<2+or 24-hour urine protein quantification<1g;
  • Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);
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  • Coagulation function: International standardized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time ≤ 1.5 × ULN;
  • Pulmonary function: First second forced expiratory volume (FEV1) ≥ 1.2 L, FEV1% ≥ 50%, carbon monoxide diffusion volume (DLCO) ≥ 50%;
  • Other: lipase ≤ 1.5 × ULN (if lipase>1.5) × ULN can be included if there is no clinical or imaging confirmation of pancreatitis; Amylase ≤ 1.5 × ULN (if amylase>1.5 × ULN can be included if there is no clinical or imaging confirmation of pancreatitis; Alkaline phosphatase (ALP) ≤ 2.5ULN.
  • 12.Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period;

Who cannot join

  • Patients who had any of the following symptoms were excluded from the study:
  • Individuals who are allergic to treatment drugs;
  • Patients who have received standard treatment for liver metastasis colorectal cancer;
  • Previously received anti-tumor therapy or radiation therapy for any malignant tumor;
  • Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy;
  • Has undergone significant surgical procedures unrelated to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
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  • Patients with extrahepatic metastasis, unresectable lymph nodes (including portal vein lymph nodes) metastasis, and primary tumor recurrence;
  • Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researchers to be highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies
  • Within 5 years, subjects have had or co-developed other malignancies requiring active treatment
  • Existence of active autoimmune diseases or immunodeficiency, or a history of autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc.
  • Individuals who test positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic hematopoietic stem cell transplantation. The following exceptions apply: Patients with a history of autoimmune hypothyroidism who have received thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar can be controlled after treatment with insulin administration scheme can participate in this study.
  • The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other therapeutic hormones) and continues to use them within 2 weeks prior to enrollment;
  • Patients who have received systemic treatment with high-dose antibiotics within the past 2 weeks;
  • Individuals who have experienced arterial/venous thrombosis events within 6 months prior to the first administration, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;
  • Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within 6 months prior to enrollment; Congestive heart failure: New York Heart Association (NYHA) grade ≥ 2; Ventricular arrhythmia requiring medication treatment (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females); Left ventricular ejection fraction (LVEF)<50%;
  • Active or uncontrolled severe infection (≥ CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, unexplained fever>38.5 ℃ before the first administration;
  • Thoracic effusion, pericardial effusion, or ascites with clinical symptoms that require frequent drainage as determined by the researcher;
  • Cirrhosis and active hepatitis; Hepatitis B reference: HBsAg is positive, and HBV DNA exceeds the upper limit of normal value (1000 copies/ml or 500 IU/ml); Patients with past hepatitis B virus (HBV) infection or cured HBV infection (defined as the presence of hepatitis B B core antibody [HBcAb] and the absence of HBsAg, and the normal HBV DNA value detected during the screening period can be included; Hepatitis C reference: HCV antibody positive, and the detection value of HCV virus titer exceeds the upper limit of the normal value/HCV RNA or HCV Ab detection indicates acute and chronic infection;
  • Urine routine indicates urine protein ≥++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0 g;
  • Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
  • Patients with pulmonary fibrosis, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe pulmonary dysfunction;
  • Pregnancy (positive pregnancy test before medication) or breastfeeding women;
  • Within 28 days prior to enrollment in this study, surgery (excluding biopsy) was performed or the surgical incision did not fully heal;
  • Received or planned to receive attenuated live vaccines within 4 weeks prior to the first administration;
  • Have received any other investigational drug treatment or participated in other intervention studies within 4 weeks prior to signing the informed consent form;
  • According to the researcher's judgment, patients who are deemed unsuitable for enrollment;

Trial locations and contacts

1 site in 1 country.

Hong Zong contact

13523586882

zonghong522@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Hong Zong

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label, Phase Ⅱ Clinical Trial of Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer

The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.

Read the detailed description

Colorectal cancer is the third largest malignant tumor in the world and a significant cause of cancer-related deaths. The probability of simultaneous liver metastasis in colorectal cancer is about 25%, and the proportion of liver metastasis occurring in the entire disease process is as high as 40% -50%. It is of great clinical significance to transform the initial unresectable liver metastases of colorectal cancer into resectable ones to improve the overall survival rate and prognosis of colorectal cancer patients. We designed a single-arm, open phase II clinical trial of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer. The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.

Being tested
Adebrelimab + Cetuximab+ Chemotherapy
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Adebrelimab + Cetuximab+ ChemotherapyDrug

    Adebrelimab:1200 mg, D1, Q2W+Cetuximab:500 mg, D1, Q2W+FOLFOX6(Q2W) or FOLFIRI(Q2W) until PD or resectability or to max 12 cycles

Study groups in NCT06231017
Study groupRoleWhat they receive
Adebrelimab + Cetuximab+ ChemotherapyExperimentalAdebrelimab + Cetuximab+ Chemotherapy
Receives: Drug: Adebrelimab + Cetuximab+ Chemotherapy

What is being measured

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

  1. Objective response rate (ORR)

    The ration of patients who are evaluated as CR or PR

    Measured: up to 1 year

Secondary outcomes (4)

  1. Progression free survival (PFS)

    Time form treament initation to the first disease progression or death from any cause

    Measured: up to 2 years

  2. Overall survival (OS)

    Time from treatment initiation until death from any reason

    Measured: up to 2 years

  3. The R0 resection rates The R0 resection rates

    The percentage of patients who had a curative (R0) liver metastasectomy following protocol treatment

    Measured: 1 year

  4. Adverse events (Safety）

    adverse events

    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 posted30 Jan 2024
  2. Study start19 Jan 2024
  3. Primary completion19 Jan 2025 (estimated)
  4. Study completion19 Jan 2026 (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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231017
Sponsor's protocol ID
S2023-K019-003
Status last verified
Jan 2024
First submitted
21 Jan 2024
Last updated
30 Jan 2024
Results posted
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 Adebrelimab + Cetuximab+ Chemotherapy in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital of Zhengzhou 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 10 inclusion and 26 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 30 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?

Contact Hong Zong (13523586882, zonghong522@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: up to 1 year). 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 NCT06231017.

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 30 Jan 2024.

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