Colorectal AdenocarcinomaPhase 3NCT06951503
AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
A Phase 3 study testing AK112, Oxaliplatin and Irinotecan in people with Colorectal Adenocarcinoma, run by Akeso at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- AK112, Oxaliplatin and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesChina
- Study dates
- 27 May 2025to 7 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, 510000
Yanhong DENG, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong
Ruihua Xu, MD
About this study
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
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.
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- AK112, Oxaliplatin, Irinotecan, Leucovorin and 5-FU, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
iv, q2w
OxaliplatinDrug
iv, q2w
IrinotecanDrug
iv, q2w
Leucovorin and 5-FUDrug
iv, q2w
BevacizumabDrug
iv, q2w
| Study group | Role | What they receive |
|---|---|---|
| AK112 in combination with FOLFOXIRI | Experimental | AK112 in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus AK112. Receives: Drug: AK112; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin and 5-FU |
| Bevacizumab in combination with FOLFOXIRI | Active comparator | Bevacizumab in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus Bevacizumab . Receives: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin and 5-FU; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by blinded independent central review (BICR)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Measured: Up to approximately 3 years
Secondary outcomes (5)
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5 years
Progression-free survival (PFS) assessed by investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
Measured: Up to approximately 3 years
Objective Response Rate (ORR)
ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria.
Measured: Up to approximately 3 years
Duration of Response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.
Measured: Up to approximately 3 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start27 May 2025
- Primary completion13 Jan 2027 (estimated)
- Study completion7 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951503
- Sponsor's protocol ID
- AK112-312
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06951503
- Acronym / sponsor ID
- AK112-312
- Conditions
- Colorectal Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 7 Jan 2029 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK112 in combination with FOLFOXIRI | Experimental | Drug: AK112, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Leucovorin and 5-FUAK112 in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus AK112. |
| Bevacizumab in combination with FOLFOXIRI | Active comparator | Drug: Oxaliplatin, Drug: Irinotecan, Drug: Leucovorin and 5-FU, Drug: BevacizumabBevacizumab in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus Bevacizumab . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK112iv, q2w | Drug | AK112 in combination with FOLFOXIRI |
| Oxaliplatiniv, q2w | Drug | AK112 in combination with FOLFOXIRI, Bevacizumab in combination with FOLFOXIRI |
| Irinotecaniv, q2w | Drug | AK112 in combination with FOLFOXIRI, Bevacizumab in combination with FOLFOXIRI |
| Leucovorin and 5-FUiv, q2w | Drug | AK112 in combination with FOLFOXIRI, Bevacizumab in combination with FOLFOXIRI |
| Bevacizumabiv, q2w | Drug | Bevacizumab in combination with FOLFOXIRI |
Primary outcome
Progression-free survival (PFS) assessed by blinded independent central review (BICR)
Time frame: Up to approximately 3 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK112, Oxaliplatin and Irinotecan in people with Colorectal Adenocarcinoma, run by Akeso at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xufang Yu, MD (+86(0760)89873999, clincialtrails@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by blinded independent central review (BICR) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.