Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC

Recruiting now · Phase 2

Conditions studied: Colorectal Cancer

In brief

A Phase II Study to Assess the Efficacy and Safety of Cadonilimab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer

Key facts

Study ID

NCT06168786

Run by

Huazhong University of Science and Technology

People needed

40

Starts

2023-06-20

Expected to finish

2027-02-28

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• MSI status: MSS
• At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities
• ECOG 0-1
• Patients must have measurable lesions
• Expected overall survival ≥12 weeks
• AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
• Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
• Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy
• Fertile male or female patients voluntarily used an effective contraceptive method during the study period and within 6 months of the last study medication

You may not qualify if…

• Patients have received anti-PD-1 / PD-L1 or anti-CTLA-4 immunotherapy or other immunoexperimental drugs
• Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc
• Symptomatic interstitial lung disease or active infection/non-infectious pneumonia
• Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation
• If the patients underwent surgery, they should wait for the wound to heal completely before being considered for enrollment
• History of other malignant tumors（(except for the cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ）
• Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplant
• Moderate or severe ascites with clinical symptoms required therapeutic puncture, drainage or Child-Pugh score >2 (except those who only show a small amount of ascites on imaging without clinical symptoms); Uncontrolled or moderate or higher pleural effusion or pericardial effusion
• History of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 6 months before the start of treatment
• Abdominal fistula, gastrointestinal perforation, or abdominal abscess developed within 6 months before the start of study treatment
• Known hereditary or acquired bleeding (e.g. coagulation dysfunction) or thrombotic tendencies, e.g. in hemophiliacs; Currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (allowing prophylactic use of low-dose aspirin, low molecular weight heparin)
• Aspirin (> 325 mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel (≥ 75 mg) and cilostazol are currently used or have been used recently (within 10 days before the start of study treatment)
• Thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism occurred within 6 months before the start of the study
• Patient with an active infection, heart failure, heart attack, unstable angina pectoris, or unstable arrhythmia within the last 6 months
• Physical examination or clinical trial findings that the investigator believes may interfere with the results or put the patient at increased risk for treatment complications, or other uncontrollable diseases
• The researchers believe that the patient has a lesion and needs emergency palliative radiotherapy / emergency surgery (spinal cord compression, brain hernia, pathological fracture)
• Lactating or pregnant women
• History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation
• Patients with mental illness, substance abuse, or social problems that affect compliance will not be enrolled after researcher's review
• Known active infection and active tuberculosis infection were not included in the group; However, patients with hepatitis B virus (HBV) and hepatitis C virus (HCV) infection can be included in the group if their condition is stable after antiviral treatment
• Patients who received live vaccine within 30 days prior to enrollment
• Have clinical symptoms or diseases of the heart that are not well controlled
• Systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs； or a history of hypertensive crisis or hypertensive encephalopathy
• Major vascular disease (such as aortic aneurysms requiring surgical repair or recent peripheral arterial thrombosis) developed within 6 months
• Severe, unhealed or open wounds and active ulcers or untreated fractures

Where it is running

• Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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