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Clinical Trials in China / NCT06951503
Recruiting Phase 3

AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

NCT06951503 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 3
Started
2025-05-27
Last updated
2026-03-04

Condition(s) studied

Colorectal Adenocarcinoma

Investigational drug(s) / intervention(s)

AK112OxaliplatinIrinotecanLeucovorin and 5-FUBevacizumab

AK112: iv, q2w

Oxaliplatin: iv, q2w

Irinotecan: iv, q2w

Leucovorin and 5-FU: iv, q2w

Bevacizumab: iv, q2w

Study summary

This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent. 2. Age ≥ 18 years and ≤ 75 years. 3. ECOG status of 0 or 1. 4. Estimated survival ≥ 3 months. 5. Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma. 6. Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll. 7. At least one measurable disease based on RECIST v1.1. 8. Adequate organ function per protocol-defined criteria. 9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment. Exclusion Criteria: 1. Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured. 2. Participating in other interventional study within 4 weeks prior to the first study drug administration. 3. Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration. 4. Current presence of uncontrolled combined disease. 5. Active clinical infections. 6. History of severe bleeding tendency or coagulation dysfunction. 7. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection. 8. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study. 9. Current presence of significant radiographic or clinical manifestations of GI obstruction. 10. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0). 11. Pregnant or lactating women. 12. Any condition considered by the investigator to be inappropriate for enrollment. 13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
The Sixth Hospital,Sun Yat-sen University Guanzhou Guangdong Recruiting
Sun Yat-sen University Cancer Center Guanzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951503 on ClinicalTrials.gov ↗ ← All trials in China