- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271813
Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)
April 22, 2024 updated by: Yuan-Sheng Zang, Shanghai Changzheng Hospital
Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC): a Single Center, Single-arm Phase II Study (APICAL-CRC)
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit.
Sintilimab is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response.
In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib and Sintilimab in advanced colorectal cancer as first-line treatment.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China
- Department of Medical Oncology, Shanghai Changzheng Hospital
-
-
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
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- Patients have histologically or cytologically confirmed advanced or recurrent CRC;
- No prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
- Patients have measurable disease as defined by RECIST 1.1 as determined by investigator;
- Patient with a history of radiotherapy at least 3 months before on the day of providing consent, but the measurable lesion should not be within the scope of radiotherapy;
- Patients with age of 18-75yr;
- Patients with a performance status of 0,1or 2 on the Eastern Cooperative Oncology Group.;
- Patients with Life expectancy of more than 12 weeks;
- Patients must have the ability to understand and sign the written informed consent voluntarily;
- Female of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients should agree to use an adequate method of contraception (total abstinence, an intrauterine device or hormone releasing system, a contraceptive implant and an oral contraceptive) starting with the first dose of study therapy through 120 days after the last dose of study therapy. Duration will be determined when the subject is assigned to treatment.
Exclusion criteria
- Patients with dMMR/MSI-H;
- Patients with major surgery or severe trauma within 4 weeks before the first medication;
- Patients with hypersensitivity to the components in the study protocol;;
- Patients who are ready to give birth or are pregnant;
- Patients with brain metastases who are unable to accurately describe the condition;
- Patients received immune-suppressive drugs 2 weeks before initial treatment (inhaled cortisol or other steroid hormones≤10 mg/day prednisone or equivalent pharmacophysiologic doses were excluded);
- Planned live attenuated vaccine within 4 weeks prior to or during study treatment;
- Patients have received anlotinib or anti-PD-1 monoclonal antibody therapy or other therapies that act on T-cell co-stimulation targets or checkpoints;
- Within 6 months prior to the start of study treatment, the following diseases appeared: myocardial infarction, severe/unstable angina, NYHA grade 2 or above congestive heart failure, poorly controlled arrhythmias, etc;
- Active hepatitis;
Bone marrow, liver and kidney function did not meet the requirements of chemotherapy as follows:
- Neutrophil count<1,500/mm3;
- Platelet count <80,000/mm3;
- Total bilirubin >1.5-times the upper limit of normal;
- ALT/AST>2.5-times the upper limit of normal for patients without liver metastases; (5.0-times the upper limit of normal for patients with liver metastases)
- Creatinine >1.5-times the upper limit of normal;
- Patients with cancers other than advanced colorectal cancer within five years prior to the start of treatment in this study. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor were excluded;
- History of substance abuse, drug use, alcohol dependence;
- Patients without legal capacity or limited civil capacity;
- Patients with autoimmune diseases or organ transplantation;
- Other situations that the investigator deemed inappropriate for enrollment;
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib and Sintilimab
the combination of Anlotinib with Sintilimab as first-line treatment
|
Anlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objecitve response rate
Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
|
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
|
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progress Free Survival
Time Frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks
|
Time from treatment beginning until disease progression
|
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks
|
Overall Survival
Time Frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks
|
Time from treatment beginning until death from any cause
|
From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks
|
Incidence of Treatment-related adverse Events
Time Frame: Through study completion, an average of 3 weeks
|
Through study completion, an average of 3 weeks
|
|
Deepness of response
Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
|
Investigation of depth of response during first-line treatment
|
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
|
Disease control rate
Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
|
Proportion of patients who achieved a complete response, a partial response, or stable diseas
|
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 1, 2020
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
February 29, 2024
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 14, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APICAL-CRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on Anlotinib plus Sintilimab
-
Sun Yat-sen UniversityNot yet recruitingNon Clear Cell Renal CarcinomaChina
-
First Hospital of Shijiazhuang CityUnknownCarcinoma | Non-small Cell Lung Cancer | Lung NeoplasmChina
-
Henan Provincial People's HospitalNot yet recruitingEsophageal Squamous Cell Carcinoma
-
Ningbo No.2 HospitalNot yet recruitingCarcinoma, Non-Small-Cell Lung
-
Henan Cancer HospitalCompletedExtensive Disease Small Cell Lung CancerChina
-
Shanghai Chest HospitalUnknownCarcinoma | Non-small Cell Lung Cancer
-
Changzhou Cancer Hospital of Soochow UniversityUnknownSmall Cell Lung CancerChina
-
Peking Union Medical College HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.; Xinda Biopharmaceutical GroupNot yet recruitingCarcinoma, Non-Small-Cell Lung
-
Sun Yat-sen UniversityCompletedRadiotherapy | Sintilimab | Anlotinib | Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type | Early Stage | Peg-aspargase | Phase Two | OpenChina
-
Zhejiang Cancer HospitalCompleted