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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Anlotinib plus sintilimab as first treatment for advanced colorectal cancer without liver metastases

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

Run by Shanghai Changzheng Hospital · NCT07398326 · Data updated 2026-11-12

This study will see if taking anlotinib together with sintilimab as the first treatment helps adults with advanced colorectal cancer that has spread outside the liver who cannot or choose not to have standard chemotherapy.

More Colorectal Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment37 (estimated)
SponsorShanghai Changzheng Hospital
Academic / other
Drugs / interventionsanlotinib, chemotherapy, radiation, prednisone, sintilimab
Locations1 site (Shanghai)
StatusRecruiting
StartedFebruary 24, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2028
Registry record updatedFebruary 9, 2026
Trial IDNCT07398326 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with histologically confirmed advanced colorectal adenocarcinoma with non-hepatic metastases, measurable disease, ECOG 0–1, life expectancy ≥12 weeks, who are systemic therapy–naïve or relapsed ≥12 months after adjuvant therapy, and who refuse chemotherapy.

Probably not a fit

Patients with liver-only metastases, poor performance status (ECOG ≥2), recent systemic therapy, or contraindications to immunotherapy or tyrosine kinase inhibitors are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives adults with histologically confirmed advanced colorectal adenocarcinoma and non-hepatic metastases a combination of oral anlotinib and intravenous sintilimab as first-line therapy. Eligible patients are chemotherapy-naïve or had relapse ≥12 months after adjuvant therapy, must have at least one measurable lesion by RECIST 1.1, and an ECOG performance status of 0–1. The study will monitor tumor response, progression-free survival, and safety with regular RECIST assessments, imaging, and laboratory testing. Prior local radiotherapy is permitted if completed ≥3 weeks before treatment and lesions used for response assessment are outside the radiation field.

Why it matters

Potential benefit: If successful, the regimen could offer an effective, lower-toxicity first-line option for patients with advanced colorectal cancer who cannot or choose not to receive standard chemotherapy.

How similar studies have gone: Combinations of antiangiogenic TKIs and PD-1 inhibitors have shown promising activity in other tumor types and early colorectal cancer cohorts, but robust evidence specifically for anlotinib plus sintilimab in non-liver metastatic CRC is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Second Affiliated Hospital of Naval Medical University
    Shanghai, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.