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Trial Title:
Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer
NCT ID:
NCT06343116
Condition:
Refractory Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Trifluridine
Nimotuzumab
Conditions: Keywords:
Nimotuzumab
trifluridine/tipiracil
metastatic colorectal cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Nimotuzumab injection
Description:
Nimotuzumab will be administered weekly (dose of nimotuzumab depends on part A) until
disease progression, unacceptable toxicity, withdrawal of consent or death due to any
cause.
Arm group label:
experimental group
Other name:
Taixinsheng
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo will be administered weekly (dose of placebo depends on part A) until disease
progression, unacceptable toxicity, withdrawal of consent or death due to any cause.
Arm group label:
control group
Intervention type:
Drug
Intervention name:
Trifluridine/tipiracil
Description:
Trifluridine/tipiracil will be administered (35 mg/m2) twice daily, 5 days a week, with 2
days of rest, for 2 weeks, followed by a 14-day rest.
Arm group label:
control group
Arm group label:
experimental group
Summary:
This is a randomized, double-blind, placebo-controlled, multicenter study. The main
purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab
combined with trifluridine/tipiracil in third-line and beyond for the treatment of
metastatic colorectal cancer (mCRC). This study planned to be divided into two parts:
Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary
endpoint is safety; Part B (main study) with a prospective, randomized, double-blind,
placebo-controlled design, which primary endpoint is overall survival (OS).
Detailed description:
This is a randomized, double-blind, placebo-controlled, multicenter study. The main
purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab
combined with trifluridine/tipiracil in third-line and beyond for the treatment of
metastatic colorectal cancer (mCRC). This study planned to be divided into two parts:
Part A and Part B. Part A is a dose escalation study, and two dose levels are set up in
terms of the dose of nimotuzumab (dose level 1: nimotuzumab 400 mg weekly; dose level 2:
nimotuzumab 600 mg weekly), while the dose of trifluridine/tipiracil remains unchanged.
The aim of this part is to investigate the safety of combination therapy and ensure the
dose of nimotuzumab in Part B. After completed the safety-run-in of Part A, Part B can be
started. In Part B (main study), a prospective, randomized, double-blind,
placebo-controlled design is proposed. Patients of this part will be stratified by tumor
site (left half of colorectal vs right half of colon), age (less than 65 years old vs 65
years old or older) and number of metastases (<3 vs ≥3) and randomly divided into
experimental group (nimotuzumab plus trifluridine/tipiracil) and control group (placebo
plus trifluridine/tipiracil) at a ratio of 2:1. Treatment will continue until disease
progression or intolerable toxicity or withdrawal of consent. In part B, the primary
endpoint is overall survival (OS); the secondary endpoint included: Progression free
survival (PFS), time to progress (TTP), overall response rate (ORR), disease control rate
(DCR), duration of response (DoR), quality of life (QoL), etc.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old, gender unlimited;
2. Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC);
3. Metastatic colorectal cancer, disease progression after previous second-line or
above standard therapy;
4. Efficacy of previous line therapy containing an anti-EGFR agent (panitumumab or
cetuximab) with complete or partial response, or disease stable; and more than 4
months from last dose of anti-EGFR agent administered before randomization;
5. MSS/pMMR status detected by IHC or PCR;
6. RAS and BRAF wild-type status;
7. ECOG Performance Status 0-1;
8. Measurable disease according to RECIST criteria v1.1;
9. Life expectancy of at least 3 months;
10. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL;
absolute neutrophil count (ANC)≥1.5×10^9/L; white Blood Cell
Count≥4×10^9/L;platelets≥100×10^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper
limit of normal (ULN), patients with liver metastases should be ≤ 5 times the ULN;
serum creatinine≤1.5×ULN or estimated creatinine clearance > 60 mL/min;
11. Women of childbearing age should have a negative result of serum HCG or urine
pregnancy tests within 72 hours prior to randomization (Postmenopausal women who
have had amenorrhea for at least 12 months are considered sterile and women known to
have had tubal ligation are not required to undergo pregnancy tests) ;
12. Good compliance and signed informed consent.
Exclusion Criteria:
1. Had other malignancies within the past 5 years or at the same time (exceptions
include: cured thyroid cancer, non-melanoma skin cancer, carcinoma in situ of the
cervix, stage I ductal carcinoma in situ, stage I endometrial cancer or other solid
tumors, and effectively treated lymphoma with no evidence of disease for more than 5
years);
2. Has a serious underlying medical condition that makes it impossible to safely
administer the trial treatment. Including but not limited to active infections
requiring systemic medication: compensatory heart failure (NYHA grade III and IV),
unstable angina, and acute myocardial infarction within 3 months prior to
enrollment;
3. Patients who received trifluridine/tipiracil or treated with EGFR monoclonal
antibody or EGFR tyrosine kinase inhibitor within four months;
4. Known allergy to prescription or any component of the prescription used in this
study;
5. Women who are pregnant or are breastfeeding;
6. Has brain metastases or any symptoms of brain metastases
7. Factors that significantly affect oral drug absorption, such as dysphagia, chronic
diarrhea, gastrointestinal obstruction, etc; Uncontrolled Crohn's disease or
ulcerative colitis;
8. Participated in other clinical trials within 4 weeks;
9. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
10. Other reasons that are not suitable to participate in this study according to the
researcher's judgment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Biotech Pharmaceutical Co., Ltd.
Agency class:
Other
Source:
Biotech Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06343116
