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Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

Primary Purpose

Colorectal Cancer, Liver Metastases, Cetuximab

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Cetuximab

Chemotherapy

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Liver Metastases, Cetuximab, Re-challenge

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary tumour was histologically confirmed colorectal adenocarcinoma;
Clinical or radiological evidence of non-resectable liver metastases;
With at least one measurable tumor;
Received first-line cetuximab (RAS gene wild type) treatment and progressed
Received second-line non-cetuximab treatment and progressed
Received circulating tumor DNA test and has RAS gene wild type status;
Performance status (ECOG) 0~1
A life expectancy of ≥ 3 months
Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
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);
Written informed consent for participation in the trial.

Exclusion Criteria:

Patients with known hypersensitivity reactions to any of the components of the study treatments.
Acute or sub-acute intestinal occlusion
Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
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
Legal incapacity or limited legal capacity
Pre-existing peripheral neuropathy.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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.

Using treatment of chemotherapy alone. Chemotherapy: detailed regimen is determined by a multi-disciplinary team

Outcomes

Primary Outcome Measures

disease control rate

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

objective response rate

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.).

progression-free survival

The period from the first day of treatment to the date of disease progression (PD) or to death.

overall survival

The period from the first day of treatment to the date of death.

Full Information

NCT ID

NCT04509635

First Posted

August 10, 2020

Last Updated

August 11, 2020

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04509635

Brief Title

Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Liver Metastases, Cetuximab

Keywords

Colorectal Cancer, Liver Metastases, Cetuximab, Re-challenge

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Using treatment of chemotherapy alone. Chemotherapy: detailed regimen is determined by a multi-disciplinary team

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

Cetuximab is used for only patients with ctDNA test RAS wild type.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.

Primary Outcome Measure Information:

Title

disease control rate

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

objective response rate

Description

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.).

Time Frame

2 years

Title

progression-free survival

Description

The period from the first day of treatment to the date of disease progression (PD) or to death.

Time Frame

2 years

Title

overall survival

Description

The period from the first day of treatment to the date of death.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary tumour was histologically confirmed colorectal adenocarcinoma; Clinical or radiological evidence of non-resectable liver metastases; With at least one measurable tumor; Received first-line cetuximab (RAS gene wild type) treatment and progressed Received second-line non-cetuximab treatment and progressed Received circulating tumor DNA test and has RAS gene wild type status; Performance status (ECOG) 0~1 A life expectancy of ≥ 3 months Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization) 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); Written informed consent for participation in the trial. Exclusion Criteria: Patients with known hypersensitivity reactions to any of the components of the study treatments. Acute or sub-acute intestinal occlusion Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding 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 Legal incapacity or limited legal capacity Pre-existing peripheral neuropathy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianmin Xu, Prof.

Phone

86-13501984869

xujmin@aliyun.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qingyang Feng, Dr.

fqy198921@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

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