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Trial Title:
Cetuximab in Combination With Dabrafenib and Tislelizumab in BRAF Mutated Treatment of Advanced Colorectal Cancer
NCT ID:
NCT05963087
Condition:
Advanced Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Cetuximab
Tislelizumab
Dabrafenib
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cetuximab Dabrafenib Tislelizumab
Description:
Dabrafenib 150mg，BID, Cetuximab 250mg/m2, Tislelizumab 200mg Treatment every three weeks
Arm group label:
Advanced CRC
Summary:
To explore the efficacy and safety of Cetuximab in combination with dabrafenib and
Tislelizumab in BRAF mutated treatment of advanced colorectal cancer
Detailed description:
Due to Encorafenib has not been marketed in China, it is difficult to benefit patients,
and there are no reported studies of Dabrafenib, also a BRAF inhibitor, in combination
with anti-EGFR monoclonal antibody and immunotherapy in BRAF mutated mCRC. Therefore, we
intend to use Dabrafenib in combination with cetuximab and Tislelizumab in the treatment
of BRAF V600E mutated patients with advanced colorectal cancer to observe the initial
efficacy and safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Histopathological diagnosis of advanced colorectal cancer; 2. Previous
first-line standard treatment failed or could not tolerate first-line standard
treatment; 3. BRAF V600E mutation (NGS or ARMS-PCR assay); 4.18 years old≤
Age≤75 years old; 5. PS score 0-1; 6. At least one measurable or evaluable
lesion according to RECIST v1.1; 7. Baseline color Doppler ultrasound: left
ventricular ejection fraction (LVEF) ≥60%; 8. Has adequate organ and bone
marrow function; 9. Expected survival ≥12 weeks 10. Female subjects of
childbearing age or male subjects whose sexual partner is a female of
childbearing age are required to take effective contraceptive measures
throughout the treatment period and for 6 months after the treatment period 11.
Sign a written informed consent and be able to comply with the visit and
related procedures required by the program;
Exclusion Criteria:
-
1. Malignant diseases other than colorectal cancer diagnosed within 5 years prior
to first administration (excluding radical treatment)Carcinomas in situ with
sexual resection); 2. Currently participating in the intervention clinical
study treatment, or receiving other study drugs or using study devices within 4
weeks before the first dose; 3. Previous treatment with BRAF inhibitors, MEK
inhibitors, anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that target
another stimulus or synergically inhibit T cell receptors (e.g., CTLA-4, OX-40,
CD137); 4. Received systemic systemic treatment with Chinese patent drugs with
anti-tumor indications or immunomodulatory drugs (including thymosin,
interferon, interleukin, except for local use to control pleural fluid) within
2 weeks before the first administration; 5. An active autoimmune disease
requiring systemic treatment (e.g. with disease-modifying drugs,
glucocorticoids, or immunosuppressants) has occurred within 2 years prior to
initial administration. Replacement therapies (such as thyroxine, insulin, or
physiologic glucocorticoids for adrenal or pituitary insufficiency) are not
considered systemic therapy; 6. Were receiving systemic glucocorticoid therapy
(excluding topical glucocorticoids by nasal spray, inhalation, or other route)
or any other form of immunosuppressive therapy within 7 days prior to initial
administration of the study 7. Known allogeneic organ transplantation (except
corneal transplantation) or allogeneic hematopoietic stem cell transplantation
8. Known allergy to any monoclonal antibody formulation ingredient (grade 3 or
above allergic reaction) 9. Has not fully recovered from toxicity and/or
complications caused by any intervention before starting treatment (i.e., ≤
grade 1 or baseline, excluding weakness or hair loss); 10. Known history of
human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy
number detected greater than the upper limit of normal value in the laboratory
of the study center); 12. Active HCV-infected subjects (HCV antibody positive
and HCV-RNA levels above the lower limit of detection); 13. Received live
vaccine within 30 days prior to the first dose (cycle 1, day 1); 14. Pregnant
or lactating women; 15. The presence of any serious or uncontrolled systemic
disease 16. Medical history or evidence of disease that may interfere with test
results, prevent participants from fully participating in the study, abnormal
treatment or laboratory test values, or other conditions that the investigator
considers unsuitable for enrollment The Investigator considers other potential
risks unsuitable for participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Institute & Hospital
Address:
City:
Hangzhou
Country:
China
Contact:
Last name:
Wangxia Lv
Phone:
13757141026
Email:
lvwangxia@163.com
Investigator:
Last name:
Hanjun Zhong
Email:
Principal Investigator
Investigator:
Last name:
Meiqin Yuan
Email:
Sub-Investigator
Investigator:
Last name:
Bixia Liu
Email:
Sub-Investigator
Investigator:
Last name:
Zhong Shi
Email:
Sub-Investigator
Investigator:
Last name:
Yazhen Zhao
Email:
Sub-Investigator
Investigator:
Last name:
Junchi Cheng
Email:
Sub-Investigator
Start date:
August 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963087
