SafetyPhase 2NCT07253896
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
A Phase 2 study testing AK104 and cetuximab or bevacizumab and FOLFIRI in people with Safety, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Safety
- What is being tested?
- AK104 and cetuximab or bevacizumab and FOLFIRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2024to 3 Jan 2027
- Phase
- Phase 2
- 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
- 1. Voluntarily sign a written ICF. 2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female. 3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
- 4. The expected survival period is ≥ 3 months. 5. Metastatic colorectal adenocarcinoma confirmed by histology or cytology. 6. Microsatellite instability (MSI) status is MSI-L or MSS type human. 7. The metastatic lesion cannot be removed and is not suitable for curative surgical treatment.
- 8. Previously only received first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX), and other systemic anti-tumor treatments for metastatic colorectal cancer are not allowed. Note: For subjects who have previously received neoadjuvant therapy, adjuvant therapy, or curative radiotherapy and chemotherapy, if disease progression occurs during or within 6 months after treatment, it is considered that they have received first-line treatment.
- According to RECIST v1.1, subjects must have at least one measurable lesion. For subjects who have previously received radiotherapy, if there are no other lesions that can be selected as target lesions and there is objective evidence of significant progression after radiotherapy, the irradiated lesions can be considered as target lesions.
- 10. The subjects are required to provide 15 recently archived or freshly obtained FFPE pathological sections of tumor tissue.
- 11. Determine good organ function through the following requirements:
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- Hematology (no use of any blood components or cell growth factor branches within 7 days prior to starting treatment)
- Holding treatment:
- Neutrophil absolute value ANC ≥ 1.5 × 109/L (1500/mm3); Ii. Platelet count ≥ 100 × 109/L (100000/mm3); Iii. Hemoglobin ≥ 90 g/L. b) Kidney: i. The calculated value of creatinine clearance rate * (CrCl) is ≥ 50 mL/min
- The Cockcroft Fault formula will be used to calculate CrCl (Cockcroft Fault formula) CrCl (mL/min)={(140- age) × Weight (kg) × F} /(SCr (mg/dL) × 72) F=1 for males; F=0.85 for women; SCr=serum creatinine. Ii Urinary protein ≤ 1+or 24-hour (h) urinary protein quantification<1.0 g. c) Liver: i. Total serum bilirubin (TBil) ≤ 1.5 × ULN; For liver metastasis or evidence to confirm/suspect Subjects with Gilbert disease, TBil ≤ 3 × ULN Ii. AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN Iii. Serum albumin (ALB) ≥ 28 g/L d) Coagulation function: i. International Standardization Ratio
Who cannot join
- 1. Patients with known MSI-H or dMMR. 2. Patients with BRAF mutations. 3. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
- 4. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
- 5. Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors.
- 6. Patients with active autoimmune diseases that require systematic treatment within the past two years (such as using medication to improve the condition, corticosteroids, immunosuppressive agents), and replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) are not considered as systematic treatment.
- 7. A history of active or previous inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).
- 8. History of immunodeficiency; HIV antibody test positive individuals; Currently using systemic corticosteroids or other immunosuppressants for a long time.
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- 9. Subjects who are known to have active pulmonary tuberculosis (TB) and suspected to have active TB need to undergo clinical examination to exclude them; Known active syphilis infection.
- 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- 11. Previous or current non infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment.
- 12. Severe infections occurring within 4 weeks prior to the first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti infective treatment within two weeks prior to the first administration (excluding antiviral treatment for hepatitis B or C).
- 13. Subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/ml (200 IU/ml) or above the lower detection limit, whichever is higher). Note: Non active or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU/mL are eligible for inclusion. Subjects with hepatitis B are required to receive anti hepatitis B virus treatment during the study treatment.
- 14. Active hepatitis C subjects (HCV antibody positive and HCV RNA levels above the detection limit).
- 15. Those who have undergone major surgical procedures or experienced severe trauma within 30 days prior to the first administration, or have planned major surgical procedures within 30 days after the first administration (as determined by the investigator); Minor local surgery performed within 3 days prior to initial administration (excluding peripheral venous puncture and central venous catheterization and intravenous infusion port implantation)
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 Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310000
Xuefeng Fang, +86-13968037427, xffang@zju.edu.cn
- Recruiting
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou
Ying Yuan, +86 13858193601, yuanying1999@zju.edu.cn
About this study
Official title: Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status
Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer
Read the detailed description
This study is a single arm, open label, single center clinical study aimed at evaluating the efficacy and safety of candenizumab combined with chemotherapy and targeted drugs (cetuximab or bevacizumab) in second-line treatment of MSS type advanced metastatic colorectal cancer.
- Conditions
- Safety
- Being tested
- AK104 and cetuximab or bevacizumab and FOLFIRI
- Keywords
- colorectal cancer, AK104, chemotherapy, cetuximab, bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104 and cetuximab or bevacizumab and FOLFIRIDrug
AK104 and cetuximab or bevacizumab and FOLFIRI as the second line
| Study group | Role | What they receive |
|---|---|---|
| AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab | Experimental | AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab Receives: Drug: AK104 and cetuximab or bevacizumab and FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
The proportion of patients whose tumor volume has decreased by 30% and can be maintained for more than 4 weeks
Measured: the proportion of lung cancer patients participating in clinical research who, after receiving treatment, achieve a significant reduction in tumor volume
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start3 Jan 2024
- Primary completion3 Jan 2026 (estimated)
- Study completion3 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Yuan, MD, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Ying Yuan, Dr, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253896
- Sponsor's protocol ID
- IR2023176
- Status last verified
- Nov 2025
- First submitted
- 29 Jan 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status
- ClinicalTrials.gov ID
- NCT07253896
- Acronym / sponsor ID
- IR2023176
- Conditions
- Safety
- Keywords
- colorectal cancer, AK104, chemotherapy, cetuximab, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 3 Jan 2026 (estimated)
- Study completion
- 3 Jan 2027 (estimated)
- First posted
- 28 Nov 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.
Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer
Detailed description
This study is a single arm, open label, single center clinical study aimed at evaluating the efficacy and safety of candenizumab combined with chemotherapy and targeted drugs (cetuximab or bevacizumab) in second-line treatment of MSS type advanced metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab | Experimental | Drug: AK104 and cetuximab or bevacizumab and FOLFIRIAK104 Combined With Chemotherapy and Cetuximab or Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Voluntarily sign a written ICF. 2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female. 3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
- 4. The expected survival period is ≥ 3 months. 5. Metastatic colorectal adenocarcinoma confirmed by histology or cytology. 6. Microsatellite instability (MSI) status is MSI-L or MSS type human. 7. The metastatic lesion cannot be removed and is not suitable for curative surgical treatment.
- 8. Previously only received first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX), and other systemic anti-tumor treatments for metastatic colorectal cancer are not allowed. Note: For subjects who have previously received neoadjuvant therapy, adjuvant therapy, or curative radiotherapy and chemotherapy, if disease progression occurs during or within 6 months after treatment, it is considered that they have received first-line treatment.
- According to RECIST v1.1, subjects must have at least one measurable lesion. For subjects who have previously received radiotherapy, if there are no other lesions that can be selected as target lesions and there is objective evidence of significant progression after radiotherapy, the irradiated lesions can be considered as target lesions.
- 10. The subjects are required to provide 15 recently archived or freshly obtained FFPE pathological sections of tumor tissue.
Key exclusion criteria (13 listed)
- 1. Patients with known MSI-H or dMMR. 2. Patients with BRAF mutations. 3. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
- 4. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.
- 5. Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors.
- 6. Patients with active autoimmune diseases that require systematic treatment within the past two years (such as using medication to improve the condition, corticosteroids, immunosuppressive agents), and replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) are not considered as systematic treatment.
- 7. A history of active or previous inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).
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 |
|---|---|---|
| AK104 and cetuximab or bevacizumab and FOLFIRIAK104 and cetuximab or bevacizumab and FOLFIRI as the second line | Drug | AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab |
Primary outcome
objective response rate
Time frame: the proportion of lung cancer patients participating in clinical research who, after receiving treatment, achieve a significant reduction in tumor volume
The proportion of patients whose tumor volume has decreased by 30% and can be maintained for more than 4 weeks
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 28 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Ying Yuan, Dr principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104 and cetuximab or bevacizumab and FOLFIRI in people with Safety, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 10 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 28 Nov 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xuefeng Fang, Dr (0571-87784718, xffang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: the proportion of lung cancer patients participating in clinical research who, after receiving treatment, achieve a significant reduction in tumor volume). 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 28 Nov 2025.