Colorectal CancerPhase 2NCT07398326
Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer
A Phase 2 study testing anlotinib and sintilimab in people with Colorectal Cancer, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Colorectal cancer (CRC) is the third most common malignant tumor worldwide and the second leading cause of cancer-related deaths. Despite recent progress in CRC research, approximately 15% to 30% of patients have metastatic lesions at the time of initial diagnosis, and another 20% to 50% of patients with primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- anlotinib and sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed advanced colorectal adenocarcinoma.
- Patients with non-hepatic metastases who explicitly refuse chemotherapy.
- Patients who have not received prior systemic therapy, or those with metastasis or recurrence occurring ≥12 months after completion of adjuvant therapy.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Prior local radiotherapy is permitted if completed at least 3 weeks before the first study drug administration; however, lesions used for RECIST evaluation must be outside the radiation field.
- Age ≥18 years.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Ability to understand and voluntarily provide written informed consent.
- For women of childbearing potential, a negative pregnancy test within 7 days prior to treatment initiation. Both patients and their partners must agree to use effective contraception during the study period.
Who cannot join
- Patients who have undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of the study drug.
- Patients with a history of hypersensitivity to any component of the study regimen.
- Patients who are planning to conceive, are pregnant.
- Patients with brain metastases who are unable to accurately describe their symptoms or condition.
- Patients with a history of autoimmune diseases or organ transplantation.
- Use of immunosuppressive medications within 2 weeks prior to the initiation of study treatment (excluding inhaled corticosteroids, or physiological replacement doses of steroids equivalent to ≤10 mg/day of prednisone).
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- Administration of a live attenuated vaccine within 4 weeks prior to the start of study treatment or planned vaccination during the study period.
- Prior treatment with anlotinib, anti-PD-1/PD-L1 monoclonal antibodies, or any other therapy targeting T-cell co-stimulation or immune checkpoint pathways.
- History of any of the following within 6 months before starting study treatment: myocardial infarction, severe/unstable angina, congestive heart failure of New York Heart Association (NYHA) Class 2 or higher, or poorly controlled cardiac arrhythmias.
- Laboratory test abnormalities meeting any of the following criteria:
- Absolute neutrophil count (ANC) <1,500/mm³.
- Platelet count <75,000/mm³.
- Total bilirubin >1.5 times the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 times ULN.
- Serum creatinine >1.5 times ULN.
- Diagnosis of any malignancy other than advanced colorectal cancer within the 5 years preceding the start of study treatment, except for carcinoma in situ of the cervix, cured basal cell carcinoma, or bladder epithelial tumors.
- Patients with colorectal cancer amenable to curative surgical resection (however, those who explicitly refuse surgery or are deemed unsuitable for surgery may be eligible).
- History of substance abuse, drug use, or alcohol dependence.
- Lack of legal capacity or limited civil capacity.
- Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Naval Medical University
Shanghai, 200003
Yuansheng Zang, 86-13816584620, doctorzangys@163.com
About this study
Official title: Phase II Study of Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer
Colorectal cancer (CRC) is the third most common malignant tumor worldwide and the second leading cause of cancer-related deaths. Despite recent progress in CRC research, approximately 15% to 30% of patients have metastatic lesions at the time of initial diagnosis, and another 20% to 50% of patients with primary localized CRC eventually develop metastatic disease. The conventional treatment for first-line metastatic colorectal cancer (mCRC) is chemotherapy based on fluorouracil combined with anti-EGFR/VEGF targeted drugs. However, some mCRC patients may not be able to receive standard dual or triple chemotherapy combined with targeted therapy due to factors such as advanced age, poor physical condition, comorbidities, or personal preferences. Therefore, exploring new, highly effective, and low-toxicity treatment regimens is of significant clinical importance. The combination of immune checkpoint inhibitors and antiangiogenic TKIs is expected to form a strong synergistic antitumor effect, which opens up a new approach for "chemotherapy-free" treatment of mCRC when the immune system is functioning normally. Previously, we conducted the APICAL-CRC study, enrolling a total of 30 patients. The clinical objective response rate (ORR) was 48.3%, the disease control rate was 89.7%, and the median progression-free survival (mPFS) and median overall survival (mOS) were 8.6 months and 22.9 months, respectively. Subgroup analysis later revealed that the ORR for non-liver metastasis patients was 70%, with an mPFS of 14.9 months, significantly higher than that of liver metastasis patients (ORR 36.8%). At the same time, patients with better physical performance scores (ECOG PS 0-1) had an ORR of 66.7%, which was superior to that of patients with ECOG PS 2 (21.4%). In terms of safety, the incidence of grade ≥ 3 treatment-related adverse events (TRAEs) for the combination of anlotinib and sintilimab was only 13.3%. Based on the preliminary results of the APICAL-CRC study, we consider further precise screening of the advantageous population among advanced CRC patients for subsequent research. We plan to limit the enrolled patients to those without liver metastasis and with ECOG PS 0-1, providing new strategies and methods for precise treatment of advanced CRC.The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with sintilimab as first-line treatment for non-liver metastatic advanced colorectal cancer. The study will be conducted at Shanghai Changzheng Hospital. The study drugs, anlotinib and sintilimab, are both marketed drugs in China.
- Conditions
- Colorectal Cancer
- Being tested
- anlotinib and 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 and sintilimabDrug
anlotinib combined with sintilimab as first-line treatment for advanced non-liver metastatic colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: anlotinib and sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start24 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhan Wang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398326
- Sponsor's protocol ID
- APICAL-CRC2
- Status last verified
- Feb 2026
- First submitted
- 13 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07398326
- Acronym / sponsor ID
- APICAL-CRC2
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 24 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (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.
Colorectal cancer (CRC) is the third most common malignant tumor worldwide and the second leading cause of cancer-related deaths. Despite recent progress in CRC research, approximately 15% to 30% of patients have metastatic lesions at the time of initial diagnosis, and another 20% to 50% of patients with primary localized CRC eventually develop metastatic disease. The conventional treatment for first-line metastatic colorectal cancer (mCRC) is chemotherapy based on fluorouracil combined with anti-EGFR/VEGF targeted drugs. However, some mCRC patients may not be able to receive standard dual or triple chemotherapy combined with targeted therapy due to factors such as advanced age, poor physical condition, comorbidities, or personal preferences. Therefore, exploring new, highly effective, and low-toxicity treatment regimens is of significant clinical importance. The combination of immune checkpoint inhibitors and antiangiogenic TKIs is expected to form a strong synergistic antitumor effect, which opens up a new approach for "chemotherapy-free" treatment of mCRC when the immune system is functioning normally. Previously, we conducted the APICAL-CRC study, enrolling a total of 30 patients. The clinical objective response rate (ORR) was 48.3%, the disease control rate was 89.7%, and the median progression-free survival (mPFS) and median overall survival (mOS) were 8.6 months and 22.9 months, respectively. Subgroup analysis later revealed that the ORR for non-liver metastasis patients was 70%, with an mPFS of 14.9 months, significantly higher than that of liver metastasis patients (ORR 36.8%). At the same time, patients with better physical performance scores (ECOG PS 0-1) had an ORR of 66.7%, which was superior to that of patients with ECOG PS 2 (21.4%). In terms of safety, the incidence of grade ≥ 3 treatment-related adverse events (TRAEs) for the combination of anlotinib and sintilimab was only 13.3%. Based on the preliminary results of the APICAL-CRC study, we consider further precise screening of the advantageous population among advanced CRC patients for subsequent research. We plan to limit the enrolled patients to those without liver metastasis and with ECOG PS 0-1, providing new strategies and methods for precise treatment of advanced CRC.The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with sintilimab as first-line treatment for non-liver metastatic advanced colorectal cancer. The study will be conducted at Shanghai Changzheng Hospital. The study drugs, anlotinib and sintilimab, are both marketed drugs in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: anlotinib and sintilimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically or cytologically confirmed advanced colorectal adenocarcinoma.
- Patients with non-hepatic metastases who explicitly refuse chemotherapy.
- Patients who have not received prior systemic therapy, or those with metastasis or recurrence occurring ≥12 months after completion of adjuvant therapy.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Prior local radiotherapy is permitted if completed at least 3 weeks before the first study drug administration; however, lesions used for RECIST evaluation must be outside the radiation field.
Key exclusion criteria (20 listed)
- Patients who have undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of the study drug.
- Patients with a history of hypersensitivity to any component of the study regimen.
- Patients who are planning to conceive, are pregnant.
- Patients with brain metastases who are unable to accurately describe their symptoms or condition.
- Patients with a history of autoimmune diseases or organ transplantation.
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 and sintilimabanlotinib combined with sintilimab as first-line treatment for advanced non-liver metastatic colorectal cancer | Drug | treatment group |
Primary outcome
Objective response rate
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
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 and sintilimab in people with Colorectal Cancer, 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 10 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuansheng Zang (86-13816584620, doctorzangys@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.