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Fruquitinib Combined With Camrelizumab in Non MSI-H/dMMR Refractory Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04866862
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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Brief Summary:
Limited agents are optional after standard first and second line treatment for mCRC. Nowadays, cancer therapy has entered the era of immunotherapy. The approved cancer therapies include pembrolizumab and nivolumab, but only for MSI-H patients. 95% of non MSI-H / dMMR patients with advanced colorectal cancer can not benefit from them. Therefore, the use of PD-1 / PD-L1 monoclonal antibody in mCRC is greatly limited. Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Drug: Combination of Fruquintinib and Camrelizumab Phase 2

Detailed Description:
Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label, Phase II, Exploratory Study of Fruquitinib Combined With Camrelizumab in Non MSI-H / dMMR Refractory Colorectal Cancer.
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Combination of Fruquintinib and Camrelizumab
Fruquintinib 5mg d1-21+ Camrelizumab 200mg d1; Repeated every 4 weeks
 Drug: Combination of Fruquintinib and Camrelizumab
Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1
Other Name: Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: up to 2 years ]
    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)


Secondary Outcome Measures :
  1. Progression-free Survival(PFS) [ Time Frame: From date of subjects until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months ]
    PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

  2. Overall Survival (OS) [ Time Frame: From assignment of the first subject until 32 death events observed, up to 2 years. ]
    OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

  3. Disease control rate (DCR) [ Time Frame: up to 2 years ]
    DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)

  4. Tumor Mutation Burden (TMB) [ Time Frame: up to 2 years ]
    The total number of somatic gene coding error, base substitution. gene insertions or deletions in every million base detected.


Other Outcome Measures:
  1. immunocytes and cell factor [ Time Frame: up to 2 years ]
    The concentration of immunocytes and cell factor in the blood of patients.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
  • Subjects with non MSI-H / dMMR metastatic colorectal cancer(CRC) (Stage IV)
  • Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
  • Subjects must not have been treated with Fruquitinib or any anti-PD-1 inhibitors.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
  • Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
  • Assigned informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Life expectancy of at least 3 months.
  • Subjects must complete the treatment and follow-up on schedule according to the research plan.
  • No brain metastasis, no spinal cord compression.
  • Subjects agree to use blood samples for study analysis.
  • Women of childbearing age must be negative in pregnancy test and willing to take effective contraceptive measures during the study period.

Exclusion Criteria:

  • Subjects are severe malnutrition or need tube feeding.
  • Radiotherapy or surgery has been performed within 30 days before treatment.
  • Previous treatment with anti-PD-1 / PD-L1 inhibitor and / or fruquitinib.
  • Other malignant tumors within 2 years and without cure (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix);
  • Subjects have active autoimmune system diseases、systemic hormone therapy or anti autoimmune drug therapy.
  • Subjects with immunodeficiency or receiving systemic steroid therapy (prednisone > 10 mg / day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days before the first dose of combination therapy in this study;
  • Subjects with active infection and still need systemic treatment 7 days before the first dose of therapy in this study.
  • Subjects with uncontrollable systemic diabetes.
  • Subjects with interstitial lung disease, non infectious pneumonia or pulmonary fibrosis;
  • Subjects who have received allogeneic organ or stem cell transplantation in the past.
  • Subjects allergic to the drugs or related components involved in this study.
  • Are participating in other interventional clinical studies.
  • The previous anti-tumor related adverses do not return to grade 1 in CTCAE before the first combination therapy.
  • Subjects who have uncontrolled hypertension by drugs, that is, systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg.
  • Thrombotic or hemorrhagic tendency or history within 60 days before the first medication, regardless of the severity.
  • Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866862


Contacts
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Contact: Yanhong Gu, Dr 00862568306714 guluer@163.com
Contact: Xiaofeng Chen, Dr 008613585172066 xiaofengch198019@126.com

Locations
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China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yanhong Gu, PHD    13813908678    guluer@163.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Chair: Rui Wang the first affilated hospital with Nanjing Medical University
More Information
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Publications of Results:

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04866862    
Other Study ID Numbers: KEEP-G 05
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
colorectal cancer
non MSI-H/dMMR
Camrelizumab
Fruquintinib
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases