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Study identifier: NCT07398326 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Colorectal Cancer  ·  Sponsor: Shanghai Changzheng Hospital

PhasePhase 2
Planned participants37
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 patien…

This description comes directly from the study's public registry record.

Talk to the study team

Yuansheng Zang  ·  86-13816584620  ·  doctorzangys@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Second Affiliated Hospital of Naval Medical UniversityShanghai, ChinaRecruiting

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