Colorectal CancerPhase 2NCT04271813
Anlotinib Plus Sintilimab as First-line Treatment for Patients With Advanced Colorectal Cancer (APICAL-CRC)
A Phase 2 study testing Anlotinib plus Sintilimab in people with Colorectal Cancer and Immunotherapy, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Immunotherapy, Anlotinib
- What is being tested?
- Anlotinib plus Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 29 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.；
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- 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.
Who cannot join
- 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);
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai
About this study
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)
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.
Read the 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.
- Conditions
- Colorectal Cancer, Immunotherapy, Anlotinib, Sintilimab, Chemo-free Therapy, First-line Treatment
- Being tested
- Anlotinib plus Sintilimab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib plus SintilimabDrug
Anlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib and Sintilimab | Experimental | the combination of Anlotinib with Sintilimab as first-line treatment Receives: Drug: Anlotinib plus Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objecitve response rate
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Secondary outcomes (5)
Progress Free Survival
Time from treatment beginning until disease progression
Measured: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 6 weeks
Overall Survival
Time from treatment beginning until death from any cause
Measured: 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
Measured: Through study completion, an average of 3 weeks
Deepness of response
Investigation of depth of response during first-line treatment
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Disease control rate
Proportion of patients who achieved a complete response, a partial response, or stable diseas
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Sheng Zang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271813
- Sponsor's protocol ID
- APICAL-CRC
- Status last verified
- Apr 2024
- First submitted
- 14 Feb 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40954146
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04271813
- Acronym / sponsor ID
- APICAL-CRC
- Conditions
- Colorectal Cancer, Immunotherapy, Anlotinib, Sintilimab, Chemo-free Therapy, First-line Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib and Sintilimab | Experimental | Drug: Anlotinib plus Sintilimabthe combination of Anlotinib with Sintilimab as first-line treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib plus SintilimabAnlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w | Drug | Anlotinib and Sintilimab |
Primary outcome
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
5 secondary outcomes
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
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
Incidence of Treatment-related adverse Events
Time frame: 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
Disease control rate
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 40954146Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib plus Sintilimab in people with Colorectal Cancer and Immunotherapy, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objecitve response rate (time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04271813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.