To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer
NCT ID:
NCT05799443
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Irinotecan
Cetuximab
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
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:
Tislelizumab
Description:
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
Arm group label:
SBRT followed by tislelizumab plus cetuximab and irinotecan
Intervention type:
Drug
Intervention name:
Irinotecan Hydrochloride
Description:
Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days.
Arm group label:
SBRT followed by tislelizumab plus cetuximab and irinotecan
Intervention type:
Drug
Intervention name:
cetuximab
Description:
cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days.
Arm group label:
SBRT followed by tislelizumab plus cetuximab and irinotecan
Intervention type:
Radiation
Intervention name:
SBRT
Description:
8-10Gy×5F，QOD
Arm group label:
SBRT followed by tislelizumab plus cetuximab and irinotecan
Summary:
To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and
irinotecan in patients with previously treated RAS wild-type advanced refractory
colorectal cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged 18-75 years
- Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0
or 1;
- Colorectal cancer diagnosed histologically and/or cytologically has metastases or
relapses that are not curable by surgery
- Have received first - and second-line systemic antitumor therapy for mCRC
(chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX,
FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs,
such as cetuximab, bevacizumab);And disease progression after second-line treatment;
- Evaluation of lung or liver metastases can be evaluated, with stereotactic
radiotherapy maneuverability;
- At least one measurable lesion as defined in RECIST version 1.1;
- Fertile patients must be willing to take effective pregnancy avoidance measures
during the study period and ≥120 days after the last dose; Female patients with
negative urine or serum pregnancy test results within 7 days or less before the
first administration of the study drug;
- Have fully understood this study and voluntarily signed informed consent.
- Adequate organ and bone marrow function, meeting the following definitions:
1. Blood routine (no blood transfusion, no granulocyte colony stimulating factor
[G-CSF], no other drug correction within 14 days before treatment);Absolute
count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count
(PLT) ≥80×109/L;
2. Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or
creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor
nutritional status before neoadjuvant therapy, patients who met the
requirements through parenteral nutrition could also be included in the
group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or
alanine aminotransferase (ALT) level ≤2.5×ULN;
Exclusion Criteria:
-
1. Pregnant or lactating women;
- Patients with a known history of allergy to any investigative drug, similar drug or
excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal
obstruction;
- Patients with a history of thromboembolism, except thrombosis caused by PICC;
- There are patients with active infection;
- Patients with unmanageable hypertension (systolic blood pressure ≥160 mmHg and
diastolic blood pressure ≥90mmHg);
- Patients with brain metastases with clinical symptoms or imaging evidence;
- Contraindications exist in treatment with other chronic diseases;
- Patients with a history of immunotherapy-related myocarditis, pneumonia, colitis,
hepatitis, nephritis, etc., with current AE ≥ grade 2;
- According to the evaluation criteria of NCI CTCAE version 5.0, there are patients
with all kinds of toxicities ≥ grade 2 due to previous treatment;
- Other conditions that the researchers determined were not suitable for inclusion in
the study.
- Received any antitumor therapy and participated in other clinical studies within 4
weeks before enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 5, 2023
Completion date:
April 5, 2025
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05799443
