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

NCT04271813 | Completed Phase 2

• 1 other identifier: APICAL-CRC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Immunotherapy; Anlotinib; Sintilimab; Chemo-free Therapy; First-line Treatment

Outcome Measures

Primary Outcomes (1)

• Objecitve response rate

  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 Outcomes (5)

• Progress Free Survival

  Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks

• Overall Survival

  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

  Through study completion, an average of 3 weeks

• Deepness of response

  Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks

• Disease control rate

  Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks

Study Arms (1)

Anlotinib and Sintilimab

EXPERIMENTAL

the combination of Anlotinib with Sintilimab as first-line treatment

Drug: Anlotinib plus Sintilimab

Interventions

Anlotinib plus Sintilimab DRUG

Anlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w

Anlotinib and Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

Location

Related Publications (1)

• Wang Z, Qin BD, Ye CY, Wang MM, Yuan LY, Yao HS, Jiao XD, Liu K, Zhou WL, Qin WX, Sun L, Dai WP, Ling Y, Wu Y, Chen SQ, Zhang YF, Shi DM, Duan XP, Zhong X, He X, Zhai WX, Zhang B, Zhang DD, Gao N, Zang YS. Anlotinib plus sintilimab as first-line treatment for patients with advanced colorectal cancer (APICAL-CRC): an open-label, single-arm, phase II trial. Signal Transduct Target Ther. 2025 Sep 16;10(1):301. doi: 10.1038/s41392-025-02383-9.

  PMID: 40954146 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

anlotinib; sintilimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: February 29, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)