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Recruiting NCT06951503

AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

Phase III Interventional Colorectal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AK112, Oxaliplatin, Irinotecan, Leucovorin and 5-FU.
Who it may be relevant to
Registry conditions: Colorectal Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer

Overview

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.

Interventions

  • Drug AK112
    iv, q2w
  • Drug Oxaliplatin
    iv, q2w
  • Drug Irinotecan
    iv, q2w
  • Drug Leucovorin and 5-FU
    iv, q2w
  • Drug Bevacizumab
    iv, q2w

Primary outcome measures

  • Progression-free survival (PFS) assessed by blinded independent central review (BICR) [Time frame: Up to approximately 3 years]
Secondary outcome measures (5)
  • Overall survival (OS) [Time frame: Up to approximately 5 years]
  • Progression-free survival (PFS) assessed by investigator [Time frame: Up to approximately 3 years]
  • Objective Response Rate (ORR) [Time frame: Up to approximately 3 years]
  • Duration of Response (DoR) [Time frame: Up to approximately 3 years]
  • Disease control rate (DCR) [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • Signed informed consent.
  • Age ≥ 18 years and ≤ 75 years.
  • ECOG status of 0 or 1.
  • Estimated survival ≥ 3 months.
  • Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
  • 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.
  • At least one measurable disease based on RECIST v1.1.
  • Adequate organ function per protocol-defined criteria.
  • 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

  • Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
  • Participating in other interventional study within 4 weeks prior to the first study drug administration.
  • 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.
  • Current presence of uncontrolled combined disease.
  • Active clinical infections.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.
  • Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.
  • Current presence of significant radiographic or clinical manifestations of GI obstruction.
  • Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
  • Pregnant or lactating women.
  • Any condition considered by the investigator to be inappropriate for enrollment.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Sixth Hospital,Sun Yat-sen University — Guanzhou
  • Sun Yat-sen University Cancer Center — Guanzhou

Identifiers

NCT: NCT06951503 · AK112-312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗