Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.
Launched by NINGBO MEDICAL CENTER LIHUILI HOSPITAL · Sep 22, 2024

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Nctid: NCT06613113

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}], "ancestors"=>[{"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M17890", "name"=>"Colorectal Neoplasms", "asFound"=>"Colorectal Cancer", "relevance"=>"HIGH"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-08-07", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2027-07-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"ORR", "timeFrame"=>"1 year", "description"=>"objective response rate"}], "secondaryOutcomes"=>[{"measure"=>"PFS", "timeFrame"=>"2 years", "description"=>"Progression Free Survival"}, {"measure"=>"OS", "timeFrame"=>"3 years", "description"=>"Overall Survival"}, {"measure"=>"DCR", "timeFrame"=>"3 years", "description"=>"Disease Control Rate"}, {"measure"=>"DoR", "timeFrame"=>"3 years", "description"=>"Duration of Overall Response"}, {"measure"=>"AE", "timeFrame"=>"3 years", "description"=>"adverse event"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["MSS Metastatic Colorectal Cancer", "Fruquintinib", "Adebrelimab", "High and Low Dose Radiotherapy"], "conditions"=>["MSS Metastatic Colorectal Cancer"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to learn about Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the treatment of second-line and above failure MSS(microsatellite stability) metastatic colorectal cancer.\n\nThe main question it aims to answer is: The efficacy and safety of Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the third line and beyond treatment of MSS metastatic colorectal cancer.\n\nParticipants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender not limited；\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1；\n3. Previously identified as MSS type mCRC；\n4. Metastatic colorectal cancer (mCRC) with disease progression after receiving standard second-line treatment according to Chinese Society of Clinical Oncology ( CSCO) guidelines；\n5. At least one measurable lesion (RECIST 1.1)；\n6. Be able to adhere to the protocol during the research period；\n7. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. For individuals with a history of uncontrolled epilepsy, central nervous system disorders, or mental disorders, the clinical severity of which may hinder the signing of informed consent forms or affect the patient's adherence to oral medication, as determined by the researcher；\n2. Accompanied by other malignant tumors that have not been cured；\n3. The baseline blood routine and biochemical indicators of the subject do not meet the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the normal upper limit; Alkaline phosphatase (ALP) ≤ 2.5 times the normal upper limit value; Serum total bilirubin\\<1.5 times the normal upper limit value; Serum creatinine\\<1 times the upper limit of normal; Serum albumin ≥ 30g/L；\n4. Serious (i.e. active) heart disease in clinical practice, such as symptomatic coronary heart disease, congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the past 12 months；\n5. Irreversible coagulation dysfunction or concurrent active massive bleeding；\n6. Combination of active infections requiring antibiotic treatment；\n7. Individuals who are allergic to any research drug ingredients；\n8. Women with concurrent pregnancy or lactation；\n9. Organ transplantation requires immunosuppressive therapy and long-term hormone therapy；\n10. Patients with autoimmune diseases；\n11. There is a history of drug treatment in previous plans。"}, "identificationModule"=>{"nctId"=>"NCT06613113", "briefTitle"=>"Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Ningbo Medical Center Lihuili Hospital"}, "officialTitle"=>"A Single-arm, Single-center Clinical Study of Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.", "orgStudyIdInfo"=>{"id"=>"KY2024PJ169"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Fruquintinib Group", "description"=>"Participants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred.", "interventionNames"=>["Drug: Fruquintinib"]}], "interventions"=>[{"name"=>"Fruquintinib", "type"=>"DRUG", "otherNames"=>["Adebrelimab", "high and low dose radiotherapy"], "description"=>"After receiving high and low dose radiotherapy on metastases, the enrolled patients will receive the combination of Fruquintinib and Adebrelimab. RECIST 1.1 standard was used for clinical tumor imaging evaluation every 6 weeks (±7 days). For complete response (CR) ,partial response (PR), or stable disease (SD), the enrolled patients will continue to receive the combination of Fruquintinib and Adebrelimab. Participants will receive the combination of Fruquintinib and Adebrelimab until disease progression or intolerable toxicity occurred.", "armGroupLabels"=>["Fruquintinib Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"315040", "city"=>"Ningbo", "state"=>"Zhejiang", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Shuang Ye, master", "role"=>"CONTACT", "email"=>"yeshuang2713@163.com", "phone"=>"+8615867883987"}], "facility"=>"Kaitai Liu", "geoPoint"=>{"lat"=>29.87819, "lon"=>121.54945}}], "centralContacts"=>[{"name"=>"Kaitai Liu, doctor", "role"=>"CONTACT", "email"=>"liukaitai@nbu.edu.cn", "phone"=>"+8613732112205"}, {"name"=>"Shuang Ye, master", "role"=>"CONTACT", "email"=>"yeshuang2713@163.com", "phone"=>"+8615867883987"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ningbo Medical Center Lihuili Hospital", "class"=>"OTHER_GOV"}, "collaborators"=>[{"name"=>"Shanghai Shengdi Pharmaceutical Co., Ltd", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}

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Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Mss Metastatic Colorectal Cancer Fruquintinib Adebrelimab High And Low Dose Radiotherapy

Description

No description provided

Gender

ALL

Eligibility criteria

Inclusion Criteria:
1. Age ≥ 18 years old, gender not limited；
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1；
3. Previously identified as MSS type mCRC；
4. Metastatic colorectal cancer (mCRC) with disease progression after receiving standard second-line treatment according to Chinese Society of Clinical Oncology ( CSCO) guidelines；
5. At least one measurable lesion (RECIST 1.1)；
6. Be able to adhere to the protocol during the research period；
7. Sign the informed consent form.
Exclusion Criteria:
1. For individuals with a history of uncontrolled epilepsy, central nervous system disorders, or mental disorders, the clinical severity of which may hinder the signing of informed consent forms or affect the patient's adherence to oral medication, as determined by the researcher；
2. Accompanied by other malignant tumors that have not been cured；
3. The baseline blood routine and biochemical indicators of the subject do not meet the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the normal upper limit; Alkaline phosphatase (ALP) ≤ 2.5 times the normal upper limit value; Serum total bilirubin\<1.5 times the normal upper limit value; Serum creatinine\<1 times the upper limit of normal; Serum albumin ≥ 30g/L；
4. Serious (i.e. active) heart disease in clinical practice, such as symptomatic coronary heart disease, congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the past 12 months；
5. Irreversible coagulation dysfunction or concurrent active massive bleeding；
6. Combination of active infections requiring antibiotic treatment；
7. Individuals who are allergic to any research drug ingredients；
8. Women with concurrent pregnancy or lactation；
9. Organ transplantation requires immunosuppressive therapy and long-term hormone therapy；
10. Patients with autoimmune diseases；
11. There is a history of drug treatment in previous plans。

About Ningbo Medical Center Lihuili Hospital

Ningbo Medical Center Lihuili Hospital is a leading healthcare institution in Ningbo, China, dedicated to advancing medical research and patient care through innovative clinical trials. With a robust infrastructure and a commitment to excellence, the hospital collaborates with a diverse team of healthcare professionals and researchers to explore cutting-edge therapies and improve treatment outcomes. Its state-of-the-art facilities and comprehensive patient support systems enable the efficient execution of clinical studies, ensuring safety and adherence to ethical standards while contributing significantly to the global medical community.

Locations

Ningbo, Zhejiang, China

People applied

0 patients applied

Timeline

First submit

September 22, 2024

Trial launched

August 07, 2024

Trial updated

September 22, 2024

Estimated completion

Not reported

Discussion 0

Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer. Launched by NINGBO MEDICAL CENTER LIHUILI HOSPITAL · Sep 22, 2024

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Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.
Launched by NINGBO MEDICAL CENTER LIHUILI HOSPITAL · Sep 22, 2024