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Metastatic Colorectal CancerNCT06551207

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

A study testing Fruquintinib, Cadonilimab and SBRT in people with Metastatic Colorectal Cancer, run by Liu Huang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Fruquintinib, Cadonilimab and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteChina
Study dates
20 Aug 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • • Patients have received anti-PD-1 / PD-L1 or anti-CTLA-4 immunotherapy or other immunexperimental drugs
  • Patients with severe autoimmune diseases: active inflammatory bowel disease (including Cohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus ervthematosus, 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)
Show all 38Show fewer
  • Patients who are preparinq for or have previously received an organ or allogenic 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 clostazol 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 > 140mmg or diastolic blood pressure > 90mmg 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
  • Received major surgery within 4 weeks prior to the start of study treatment (except for diagnosis or expected to require major surgery during the study period
  • Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption
  • Had a history of intestinal obstruction and/or had clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to initiation of study therapy, including incomplete obstruction related to pre-existing disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding
  • Patients with signs/symptoms of incomplete obstruction/obstructive syndrome/ileus at initial diagnosis may be admitted to the study if they have received definitive (surgical) treatment to resolve symptoms
  • There is evidence of abdominal gas accumulation that cannot be explained by puncture or recent surgical procedures
  • Metastatic disease involvina a maior airway or blood vessel or a large mediastinal tumor mass located in the center (<30 mm from the crest)
  • Patients with a history of hepatic encephalopathy For those who currentlv have interstitial oneumonia or interstitial luna disease, or who have a history of interstitial pneumonia or interstitial luna disease requiring hormone therapv. Or other
  • Patients with a history of hepatic encephalopathy
  • For those who currently have interstitial pneumonia or interstitial lung disease, or who have a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, Or other subjects with pulmonary fibrosis, institutionalized pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and management of immune-related pulmonary toxicity, or with evidence of active pneumonia or severe impairment of lung function visible on chest CT during the screening period, radiation pneumonia is allowed in the radiation field: Active tuberculosis
  • Presence of active autoimmune disease or history of autoimmune disease with possible recurrence; Participants with non-systemic skin diseases such as vitiligo, psoriasis, and alopecia, controlled type 1 diabetes treated with insulin, or asthma in complete remission in childhood, were enrolled without any intervention as adults; Patients with asthma who require medical intervention with bronchodilators are not included
  • Use of immunosuppressants or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study therapy
  • Known history of severe allergy to any monoclonal antibody, anti-angiogenesis targeting drug Severe infection, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, in the 4 weeks prior to initiation of study treatment; Therapeutic antibiotics were given orally or intravenously within 2 weeks prior to the start of study therapy
  • According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study. There are serious abnormalities in laboratory examination, accompanied by family or social factors, which will affect the safety of the patient

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianglin Yuan, PhD,MD contact

13667241722

Xlyuan1020@163.com

China1 site, 1 recruiting

  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Xianglin Yuan, PhD,MD, 8627-83663406, xlyuan1020@163.com

    Recruiting

Other trials in China

About this study

Official title: Fuquinitinib Combined With Cardonilizumab and SBRT Versus Fuquinitinib in Third-line and Post-line Treatment of Metastatic Colorectal Cancer: a Randomized, Controlled, Open, Multicenter Clinical Study

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

Being tested
Fruquintinib, Cadonilimab, SBRT
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FruquintinibDrug

    Fruquintinib:5mg ,qd,po, d1-d14, q3w

  • CadonilimabDrug

    Cadonilimab:10mg/kg, ivgtt, d1, q3w

  • SBRTRadiation

    SBRT:8-10Gy×5F, god, in 10 days

Study groups in NCT06551207
Study groupRoleWhat they receive
fuquintinibPlacebo comparatorNot described
Receives: Drug: Fruquintinib
Fuquintinib combined with cardonilizumab and SBRTExperimentalNot described
Receives: Drug: Fruquintinib; Drug: Cadonilimab; Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    6-month progression-free survival in patients with third-line and postline metastatic colorectal cancer mCRC with cardonilizumab combined with fuquinitinib and SBRT compared with fuquinitinib monotherapy (6mon-PFS)

    Measured: 6mon-PFS

Secondary outcomes (5)

  1. Obiective response rate (ORR)

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

    Measured: up to 42 months]

  2. Disease control rate (DCR)

    Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.

    Measured: up to 42 months]

  3. Overall survival (OS)

    The time interval between the start date of study drug and the date of death (any cause)

    Measured: up to 42 months]

  4. quality of life (QOL)

    OOL according to OOL-C30

    Measured: up to 42 months]

  5. 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.

    Measured: up to 42 months]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start20 Aug 2024 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551207
Sponsor's protocol ID
2024TJCR020
Status last verified
Aug 2024
First submitted
9 Aug 2024
Last updated
13 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fruquintinib, Cadonilimab and SBRT in people with Metastatic Colorectal Cancer, run by Liu Huang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianglin Yuan, PhD,MD (13667241722, Xlyuan1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 6mon-PFS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06551207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.

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