Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer

NCT05799443 | Unknown Phase 2

• 1 other identifier: STEC
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR

  From enrollment to 12 month

Secondary Outcomes (2)

• Progression-Free Survival(PFS)

  From enrollment to 12 month

• Overall Survival (OS)

  From enrollment to 12 month

Study Arms (1)

SBRT followed by tislelizumab plus cetuximab and irinotecan

EXPERIMENTAL

Drug: Tislelizumab; Drug: Irinotecan Hydrochloride; Drug: cetuximab; Radiation: SBRT

Interventions

Tislelizumab DRUG

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

SBRT followed by tislelizumab plus cetuximab and irinotecan

Irinotecan Hydrochloride DRUG

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

SBRT followed by tislelizumab plus cetuximab and irinotecan

cetuximab DRUG

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

SBRT followed by tislelizumab plus cetuximab and irinotecan

SBRT RADIATION

8-10Gy×5F，QOD

SBRT followed by tislelizumab plus cetuximab and irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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;

You may not qualify if:

• \. 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;
• Received any antitumor therapy and participated in other clinical studies within 4 weeks before enrollment.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab; Irinotecan; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 5, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share