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Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

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ClinicalTrials.gov Identifier: NCT04509635
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Fudan University

Study Description
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Brief Summary:
For patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. This is called the cetuximab re-challenge. And the circulating tumor DNA (ctDNA) test is reported a biomarker for the efficacy of cetuximab rechallenge. However, there is still no randomized controlled trial for verification. This study aims at patients after the first-line treatment of cetuximab has progressed. After the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Liver Metastases Cetuximab Drug: Cetuximab Drug: Chemotherapy Phase 3

Detailed Description:
Patients with colorectal cancer liver metastases were RAS wild type, received first-line cetuximab plus chemotherapy. After first-line progression, second-line non-cetuximab treatment were used. After second-line progression, ctDNA is test, and patients with RAS wild-type are enrolled in the study to compare cetuximab plus chemotherapy vs. chemotherapy alone as third-line treatment. Treatment will continue until disease progression or unacceptable toxic effects. The primary endpoint is the disease control rate，which will be assessed by local multidisciplinary team with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 4 cycles up to 12 cycles.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Cetuximab Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Liver Metastasis With Progression After First-line Treatment of Cetuximab
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
Using treatment of cetuximab plus chemotherapy. Cetuximab: 500 mg/m2 IV over 2 hours, day 1, every 2 weeks. Chemotherapy: detailed regimen is determined by a multi-disciplinary team.
 Drug: Cetuximab
Cetuximab is used for only patients with ctDNA test RAS wild type.

Drug: Chemotherapy
The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.
Active Comparator: Arm B
Using treatment of chemotherapy alone. Chemotherapy: detailed regimen is determined by a multi-disciplinary team
 Drug: Chemotherapy
The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. disease control rate [ Time Frame: 2 years ]
    According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD), evaluated by radiology (CT, MRI, etc.).


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: 2 years ]
    According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR) and partial response (PR), evaluated by radiology (CT, MRI, etc.).

  2. progression-free survival [ Time Frame: 2 years ]
    The period from the first day of treatment to the date of disease progression (PD) or to death.

  3. overall survival [ Time Frame: 2 years ]
    The period from the first day of treatment to the date of death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary tumour was histologically confirmed colorectal adenocarcinoma;
  2. Clinical or radiological evidence of non-resectable liver metastases;
  3. With at least one measurable tumor;
  4. Received first-line cetuximab (RAS gene wild type) treatment and progressed
  5. Received second-line non-cetuximab treatment and progressed
  6. Received circulating tumor DNA test and has RAS gene wild type status;
  7. Performance status (ECOG) 0~1
  8. A life expectancy of ≥ 3 months
  9. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
  10. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 5 x ULN(within 1 week prior to randomization);
  11. Written informed consent for participation in the trial.

Exclusion Criteria:

  1. Patients with known hypersensitivity reactions to any of the components of the study treatments.
  2. Acute or sub-acute intestinal occlusion
  3. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  4. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Known drug abuse/ alcohol abuse
  5. Legal incapacity or limited legal capacity
  6. Pre-existing peripheral neuropathy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509635


Contacts
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Contact: Jianmin Xu, Prof. 86-13501984869 xujmin@aliyun.com
Contact: Qingyang Feng, Dr. fqy198921@163.com

Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Fudan University
ClinicalTrials.gov Identifier: NCT04509635    
Other Study ID Numbers: Cet-rechallenge
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fudan University:
Colorectal Cancer
Liver Metastases
Cetuximab
Re-challenge
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents