Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06551207

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

Led by Liu Huang · Updated on 2024-08-13

80

Participants Needed

1

Research Sites

175 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

An assessment of 6-month progression-free survival in patients with mCRC with third-line and postline metastatic colorectal cancer in combination with cardonilizumab and fuquinitinib and SBRT compared with fuquinitinib monotherapy

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent before any study procedures
  • Age between 18 and 75 years
  • Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer
  • Microsatellite stable (MSS) status
  • Received at least two or more prior standard systemic therapies including Fu, oxaliplatin, irinotecan, bevacizumab, and cetuximab, with treatment failure or intolerable toxicities
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Presence of measurable lesions
  • Expected overall survival of at least 12 weeks
  • Liver function tests (AST, ALT, alkaline phosphatase) less than or equal to 2.5 times the upper limit of normal
  • Serum bilirubin less than or equal to 1.5 times the upper limit of normal
  • Creatinine within normal limits
  • Prothrombin time and international normalized ratio (INR) less than or equal to 1.5 times the upper limit of normal
  • Allowed prior radiotherapy if more than 4 weeks have passed since treatment and radiotherapy lesions are different from evaluable lesions
  • Fertile male or female patients agreeing to use effective contraception during the study and for 6 months after last study medication
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4 immunotherapy, or other experimental immunotherapies
  • Severe autoimmune diseases such as active inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or autoimmune vasculitis
  • Symptomatic interstitial lung disease or active infection/non-infectious pneumonia
  • Risk factors for intestinal perforation including active diverticulitis, abdominal abscess, gastrointestinal obstruction, or abdominal cancer
  • Recent surgery without complete wound healing
  • History of other malignant tumors except cured localized tumors like basal cell carcinoma or carcinoma in situ
  • Previous or planned organ or allogenic bone marrow transplant
  • Moderate or severe ascites requiring treatment or significant pleural/pericardial effusion
  • Recent gastrointestinal bleeding or conditions predisposing to bleeding within 6 months
  • Abdominal fistula, gastrointestinal perforation, or abscess within 6 months
  • Known bleeding or clotting disorders or recent use of full-dose anticoagulants or antiplatelet agents beyond low-dose aspirin or low molecular weight heparin
  • Recent thrombosis or embolism events within 6 months
  • Active infection, heart failure, heart attack, unstable angina, or arrhythmia within 6 months
  • Conditions increasing risk for treatment complications or uncontrolled diseases
  • Need for emergency palliative radiotherapy or surgery
  • Pregnant or lactating women
  • Immunodeficiency including HIV or organ transplantation
  • Mental illness, substance abuse, or social issues affecting compliance
  • Active infections including tuberculosis; stable hepatitis B or C allowed
  • Recent live vaccine within 30 days
  • Uncontrolled heart disease or hypertension
  • Major vascular diseases requiring surgery or recent thrombosis
  • Severe wounds, ulcers, or fractures
  • Recent major surgery within 4 weeks
  • Inability to swallow tablets or malabsorption
  • History or signs of gastrointestinal obstruction within 6 months
  • Evidence of unexplained abdominal gas accumulation
  • Metastatic disease involving major airway, blood vessel, or large mediastinal tumor
  • History of hepatic encephalopathy
  • Interstitial lung disease requiring hormone therapy or active pneumonia affecting lung function
  • Active or history of autoimmune disease with risk of recurrence except certain controlled conditions
  • Recent use of immunosuppressants or systemic corticosteroids
  • Severe allergy to monoclonal antibodies or anti-angiogenesis drugs
  • Recent severe infection requiring hospitalization or antibiotics
  • Other factors judged by investigators to affect study safety or results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

X

Xianglin Yuan, PhD,MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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