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

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2025-04-05

Brief 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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SBRT followed by tislelizumab plus cetuximab and irinotecan

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Irinotecan Hydrochloride

Intervention Type: DRUG

Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days.

cetuximab

Intervention Type: DRUG

cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days.

SBRT

Intervention Type: RADIATION

8-10Gy×5F，QOD

Interventions

Tislelizumab

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Intervention Type: DRUG

Irinotecan Hydrochloride

Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days.

Intervention Type: DRUG

cetuximab

cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days.

Intervention Type: DRUG

SBRT

8-10Gy×5F，QOD

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

STEC

Identifier Type: -

Identifier Source: org_study_id