Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer

Phase II Study of Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer

Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer (NCT07398326) is a Phase 2 interventional studying Colorectal Cancer, sponsored by Shanghai Changzheng Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Colorectal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 37 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with diagnosed by tissue sample (biopsy-confirmed) advanced colorectal adenocarcinoma. - Patients with non-hepatic metastases who explicitly refuse chemotherapy. - Patients who have not received previous cancer treatment that works throughout the body (like chemotherapy), 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. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Life expectancy ≥12 weeks. - Ability to understand and voluntarily provide written willing to sign a consent form. - 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 Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body)s 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). - Administration of a live attenuated vaccine within 4 weeks prior to the start of study treatment or planned vaccination during the study period. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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). * 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: 1. Absolute neutrophil count (ANC) \<1,500/mm³. 2. Platelet count \<75,000/mm³. 3. Total bilirubin \>1.5 times the upper limit of normal (ULN). 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 times ULN. 5. 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.

Treatments Being Tested

DRUG

anlotinib and sintilimab

anlotinib combined with sintilimab as first-line treatment for advanced non-liver metastatic colorectal cancer

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Second Affiliated Hospital of Naval Medical University

Shanghai, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07398326), the sponsor (Shanghai Changzheng Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07398326 clinical trial studying?

Who can participate in NCT07398326?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07398326?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT07398326. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07398326. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.