A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)

June 22, 2020 updated by: Zhejiang Cancer Hospital
This is an open-label, single center, non-randomized, phase Ⅱ trial to evaluate safety and efficacy of using the combination treatment of Camrelizumab with anti-angiogenic drugs and Chemotherapy of metastatic colorectal mucinous adenocarcinoma(MAC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Colorectal cancer contains multiple pathological types, and one of the more special pathological types is mucinous adenocarcinoma. The prognosis of patients with mucinous adenocarcinoma is not ideal.Some molecular and genetic factors may be related to the characteristics of mucinous adenocarcinoma, in which microsatellite instability and loss of mismatch repair proteins are a focus of current research. Microsatellite instability is often associated with poor differentiation and higher tumor stage. Adenocarcinoma that secretes a large amount of mucus in pathological features.so,In this study, the incidence of ORR and AEs was the main endpoint, and the efficacy and safety of Camrelizumab combined with anti-angiogenic drugs in the treatment of advanced colorectal mucinous adenocarcinoma were observed and evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Luo Cong, Doctor of Oncology
  • Phone Number: 13456711894
  • Email: lw939291@126.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Zhejiang Province Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Join the study voluntarily and sign the informed consent;
  • 2. Unresectable locally advanced or metastatic colorectal mucinous adenocarcinoma or colorectal adenocarcinoma containing mucinous gland components diagnosed by histopathology or cytology;
  • 3. Patients who have received at least first-line and above systemic chemotherapy (which may include platinum, fluorouracil, or irinotecan-based) progress or intolerance (maintenance treatment progress after first-line chemotherapy can also be included). Simultaneous chemoradiotherapy for recurrence or metastasis after surgery is considered as first-line treatment; for radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, It should be counted as a failure of first-line treatment;
  • 4. Age 18-75 years old (including boundary value, calculated on the day of signing informed consent), both men and women;
  • 5. ECOG score 0-2 points;
  • 6. Blood routine and liver and kidney function meet the following conditions: neutrophil count>1.5*10^9/L, hemoglobin concentration>90g/L, platelet count>80*109/L; ALT and AST<2.0*ULN (with liver The transferee may be <5.0*ULN);
  • 7. Estimated survival time> 3 months;
  • 8. Willing to accept long-term follow-up, willing to provide tumor tissue samples, willing to provide blood samples before and after treatment;

Exclusion Criteria:

  • 1. Known predisposition of inherited or acquired bleeding and thrombosis (such as hemophiliacs, coagulopathy, thrombocytopenia, etc.);
  • 2. Urinary routines suggest that urine protein ≥ ++ and a confirmed 24-hour urine protein amount> 1.0 g;
  • 3. Suffering from active infection, or unexplained fever within 7 days before medication ≥ 38.5℃, or baseline white blood cell count> 15×109/L;
  • 4. There are contraindications for immunotherapy (including long-term use of hormones, radiation pneumonia has not been cured and cured within 3 months, etc.);
  • 5. Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.);
  • 6. Patients with active hepatitis B or C, HIV patients, active tuberculosis, etc.;
  • 7. Active infection requires antimicrobial treatment (for example, antibacterial drugs, antiviral drugs, antifungal drugs);
  • 8. Known history of allogeneic organ transplantation and history of transplanted hematopoietic stem cells;
  • 9. Patients with interstitial lung disease or previous history of interstitial pneumonia;
  • 10. Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders;
  • 11. Participated in clinical trials of other anti-tumor drugs within 2 weeks before enrollment;
  • 12. Those who have used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
  • 13. Previous or concurrently suffering from other uncured malignant tumors, cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer can be included;
  • 14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
  • 15. According to the investigator's judgment, there are other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, and there are serious laboratory abnormalities , Accompanied by family or social factors, will affect the safety of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Two-drug group
Camrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
Drug: Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)
Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma
Experimental: Three-drug group
Camrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days;
Drug: Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan
Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ORR：Objective Response Rate
Time Frame: through study completion, an average of 2 year
Objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1
through study completion, an average of 2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
DCR: disease control rate
Time Frame: through study completion, an average of 2 year
partial rate of subjects evaluated as CR/PR/SD in all subjects
through study completion, an average of 2 year
PFS: progression-free survival
Time Frame: through study completion, an average of 2 year
time from randomization to progression and death
through study completion, an average of 2 year
OS: overall survival
Time Frame: through study completion, an average of 2 year
time from randomization to death
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ChiECRCT20200108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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