SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab in First-line Treatment of mCRC

NCT05438108 | Unknown Phase 2 DMC

• 1 other identifier: TJCC013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Immune checkpoint inhibitors have a poor effect on MSS colorectal cancer. Studies have shown that SBRT, chemotherapy and anti-vascular therapy can enhance the anti-tumor effect of PD-1 antibody. This is a prospective, single-arm study to explore the efficacy and safety of SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab in treatment with patients with initially unresectable advanced colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Keywords

mCRC; SBRT; chemotherapy; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  CR + PR rate according to the RECIST version 1.1 guidelines.

  up to 12 months

• AEs

  Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.

  up to 36 months

Secondary Outcomes (3)

• Disease control rate (DCR)

  up to 12 months

• Progression-free survival (PFS)

  up to 18 months

• Overall survival (OS)

  up to 36 months

Study Arms (1)

SBRT sequential chemotherapy, bevacizumab and sitilimab

EXPERIMENTAL

Combination Product: SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab

Interventions

SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab COMBINATION_PRODUCT

SBRT Sequential CapeOX Regimen Chemotherapy Combined With Bevacizumab and Sintilimab

SBRT sequential chemotherapy, bevacizumab and sitilimab

Eligibility Criteria

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

You may qualify if:

• Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
• Age ≥ 18 years, ≤75 years;
• Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer,metastases cannot be removed;
• No prior systemic treatment for advanced or metastatic colorectal cancer (including chemical therapy, epidermal growth factor receptor inhibitors such as cetuximab or panizumab, vascular endothelial growth factor inhibitors such as bevacizumab, immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies and anti-CTLA-4 antibodies);
• The interval between adjuvant or neoadjuvant chemotherapy is more than one year;
• According to the definition of RECIST 1.1, the investigator determined that the patient had at least one measurable disease;
• At least one lesion is suitable for SBRT according to the evaluation of the researchers;
• Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be enrolled as long as they meet the following conditions:
• \) Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or no exacerbation of symptoms for at least 2 weeks; 3) no glucocorticoid treatment or discontinuation of glucocorticoid treatment within 7 days prior to administration of the first study drug;
• ECOG 0-1;
• \. Life expectancy \>3 months;
• \. LVEF ≥50%;
• Adequate organ function, subject will meet the following laboratory criteria:
• Absolute value of neutrophil (ANC) ≥1.5x109/L.
• Platelet ≥90×109/L.

You may not qualify if:

• Prior treatment with anti-PD-L1, anti-PD-L2 drugs, or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137);
• Symptomatic or high-risk obstruction, bleeding, perforation, pneumonia (including noninfectious pneumonia with prior hormone therapy and pneumonia patients under treatment), etc;
• Other malignant diseases other than colorectal cancer were diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resected carcinoma in situ);
• Subject is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing;
• An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic;
• Subjects were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to study initial dosing;
• Active hemoptysis (cough up at least 2.5ml or 1/2 teaspoon blood at a time) within 3 months prior to administration of the drug in the first study;
• Imaging shows tumor invasion/invasion of large vessels or bleeding tendency as assessed by investigator or radiologist;
• Had major surgery within 4 weeks prior to administration of the first study drug (except for surgery for biopsy purposes) or expected to have major surgery during the study period;
• Severe unhealed wounds, ulcers or fractures;
• Current or recent use of aspirin (within 10 days prior to receiving the first study dose) for 10 consecutive days (\> 325 mg/ day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function; Current or recent (within 10 days prior to receiving the first study dose) treatment with a full-dose oral or parenteral anticoagulant or thrombolysis agent for 10 consecutive days;
• Hereditary bleeding tendency or coagulopathy;
• Digestive diseases such as active gastrointestinal ulcer, ulcerative colitis, intestinal obstruction, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation
• Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known;
• Known allergy to oxaliplatin, capecitabine, sindilizumab or bevacizumab active ingredients or excipients;

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Xianglin Yuan

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; sintilimab

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xianglin Yuan

CONTACT

+8613667241722; yuanxianglin@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: SBRT Sequential CapeOX Regimen Combined With Bevacizumab and Sintilimab

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2024
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

CN (1)