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Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)

Primary Purpose

Colorectal Cancer, Immunotherapy, Anlotinib

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib plus Sintilimab
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum (metastatic colorectal cancer);
  • no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
  • at least one measurable lesion;
  • received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
  • ECOG performance status 0-1;
  • the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN), ALT and AST <2.5 × ULN and if liver metastases, BIL < 3 × ULN, ALT and AST <5 × ULN; Serum Cr ≤ 1.5 × ULN;
  • Patient's written declaration of consent obtained;
  • Estimated life expectancy > 12 months;

Exclusion Criteria:

  • harboring dMMR/MSI-H;
  • Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
  • received anlotinib or other immune checkpoint inhibitor ;
  • with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
  • severe wounds or surgery 4 weeks before recruitment;
  • received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
  • History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.
  • pregnancy or breast feeding;
  • absent or restricted legal capacity;
  • a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study

Sites / Locations

  • Department of Medical Oncology, Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anlotinib and Sintilimab

Arm Description

the combination of Anlotinib with Sintilimab as first-line treatment

Outcomes

Primary Outcome Measures

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Secondary Outcome Measures

Progress Free Survival
Time from treatment beginning until disease progression
Overall Survival
Time from treatment beginning until death from any cause
Incidence of Treatment-related adverse Events
Deepness of response
Investigation of depth of response during first-line treatment

Full Information

First Posted
February 14, 2020
Last Updated
September 23, 2023
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04271813
Brief Title
Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Immunotherapy, Anlotinib, Sintilimab, Chemo-free Therapy, First-line Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib and Sintilimab
Arm Type
Experimental
Arm Description
the combination of Anlotinib with Sintilimab as first-line treatment
Intervention Type
Drug
Intervention Name(s)
Anlotinib plus Sintilimab
Intervention Description
Anlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w
Primary Outcome Measure Information:
Title
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Time Frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Secondary Outcome Measure Information:
Title
Progress Free Survival
Description
Time from treatment beginning until disease progression
Time Frame
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks
Title
Overall Survival
Description
Time from treatment beginning until death from any cause
Time Frame
From date of treatment beginning until the date of death from any cause, through study completion, an average of 3 weeks
Title
Incidence of Treatment-related adverse Events
Time Frame
Through study completion, an average of 3 weeks
Title
Deepness of response
Description
Investigation of depth of response during first-line treatment
Time Frame
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum (metastatic colorectal cancer); no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy; at least one measurable lesion; received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria; ECOG performance status 0-2; the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN), ALT and AST <2.5 × ULN and if liver metastases, BIL < 3 × ULN, ALT and AST <5 × ULN; Serum Cr ≤ 1.5 × ULN; Patient's written declaration of consent obtained; Estimated life expectancy > 12 weeks; Exclusion Criteria: harboring dMMR/MSI-H; Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification); received anlotinib or other immune checkpoint inhibitor ; with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ; severe wounds or surgery 4 weeks before recruitment; received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents; History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively. pregnancy or breast feeding; absent or restricted legal capacity; a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
Facility Information:
Facility Name
Department of Medical Oncology, Shanghai Changzheng Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhan Wang
Phone
+86-13916229609
Email
13916229609@139.com
First Name & Middle Initial & Last Name & Degree
Yuan-Sheng Zang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)

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