MSS/pMMR Type Metastatic Colorectal Adenocarcinoma PatientsNCT06936488
A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer
A study testing Ivonescimab,TAS-102 in people with MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients, run by Huai'an First People's Hospital at 1 site in China.
Trial summary
A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer Main purpose: Evaluate the efficacy and safety of the combination therapy of Ivonescimab (AK112) and TAS-102 in the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients
- What is being tested?
- Ivonescimab,TAS-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- 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
- Age: 18 years old and above but 75 years old and below, regardless of gender;
- Previously received at least two standard chemotherapy regimens for advanced colorectal cancer and demonstrated disease progression or intolerance to the last regimen.
- Patients who have received adjuvant/neoadjuvant chemotherapy and experience recurrence during or within 6 months after completion of adjuvant/neoadjuvant chemotherapy can be considered as a chemotherapy regimen for advanced disease;
- There are sufficient tissue specimens that have been tested as pMMR (immunohistochemistry) or MSS (PCR or NGS)
- Have at least one measurable lesion (RECIST v1.1);
- ECOG PS score is 0 or 1;
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- Expected survival exceeds 3 months;
- The main organ functions are normal, which meets the following criteria:
- Absolute neutrophil count ≥ 1.5 x 10 ^ 9/L Hemoglobin ≥ 9 g/dL Platelet count ≥ 100 x 10 ^ 9/L Creatinine clearance rate ≥ 50 mL/min, evaluated using the Cockcroft\&Gault formula Serum total bilirubin<1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) ≤ 2.5 x ULN (unless liver metastasis leads to abnormal liver function, aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 5 x ULN) All patients have normal coagulation function. For patients receiving anticoagulant therapy (excluding platelet anticoagulants), it should be confirmed that the INR has reached a sufficient therapeutic level.
- The subjects voluntarily joined this study and signed informed consent forms, demonstrating good compliance and cooperation with follow-up;
- Women with fertility: must agree to use reliable methods of contraception for at least 180 days from the signing of the informed consent form until the last administration of the study drug. And the serum HCG test must be negative within 7 days before starting the study treatment; And it must be non lactating. If a female patient has already menstruated, has not yet reached postmenopausal status (continuous absence of menstruation for ≥ 12 months, no other reasons found besides menopause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), it is considered that the patient has fertility;
- For male patients whose partners are women with fertility, they must agree to use reliable methods of contraception for at least 180 days from the signing of the informed consent form until the last administration of the study drug. Male patients must also agree not to donate sperm during the same time period.
Who cannot join
- Previously received TAS-102 treatment.
- Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-CD47 antibodies, anti-SIRP α antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immunotherapy, and any other treatment targeting the immune mechanism of tumor.
- Severe wounds that do not heal, ulcers that do not heal, or fractures that do not heal.
- Known coagulation disorders and bleeding disorders that increase the risk of bleeding.
- Researchers believe that patients are unlikely to comply with oral medication treatment plans or study requirements for scheduled evaluations.
- Pregnant, lactating women or those who may become pregnant during the study period.
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- Symptomatic central nervous system metastasis with unstable nervous system or the need to increase steroid dosage to control central nervous system diseases.
- Suffering from severe or uncontrolled active acute or chronic infections.
- Suffering from interstitial lung disease and/or pneumonia, or pulmonary arterial hypertension.
- Researchers believe that uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
- 11. Study whether there have been deep arterial thromboembolic events, including cerebrovascular accidents or myocardial infarction, within 6 months prior to the start of the first treatment. Study the occurrence of deep vein thromboembolism events within 4 weeks prior to the first treatment.
- 12. Severe/unstable angina, symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV.
- 13. Other malignant tumors, including those that have received curative treatment and have a remission period of less than 5 years during screening. Patients with cervical carcinoma in situ and basal cell carcinoma who can be cured with appropriate treatment are exempt from this minimum required remission period.
- Receive systemic immunosuppressive therapy (excluding prophylactic or long-term low-dose steroids [≤ 20 mg/day prednisone equivalent]).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#
Huai'an, Jiangsu, 210000
About this study
A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer
Main purpose:
Read more
Evaluate the efficacy and safety of the combination therapy of Ivonescimab (AK112) and TAS-102 in the treatment of refractory MSS/pMMR advanced colorectal cancer
Exploratory purpose:
Evaluation of the relationship between immune markers, patient efficacy, and prognosis in the treatment of refractory MSS/pMMR advanced colorectal cancer with the combination of Ivonescimab (AK112) and TAS-102 Study endpoint
Primary endpoint:
Researchers evaluated the PFS rate at 18 weeks based on RECIST v1.1.
Secondary endpoint:
ORR, DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)
- Being tested
- Ivonescimab,TAS-102
- Keywords
- intestinal cancer，Ivonescimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab,TAS-102Drug
Ivonescimab,20mg/kg,i.v.,D1,Q3w TAS-102,35mg/m2,bid,D1-5,Q2W
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab | Experimental | Not described Receives: Drug: Ivonescimab,TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS rate at 18 weeks
The progression free survival rate (PFS) at 18 weeks refers to the proportion of patients who have experienced objective deterioration or progression (including death) of the disease for the first time since the start of treatment, and whose survival time has reached or exceeded 18 weeks
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (2)
Overall response rate (ORR)
The ORR is defined as the proportion of patients with a response of CR or PR
Measured: At the end of Cycle 6 (each cycle is 28 days)
Overall survival (OS)
From the date of randomization until the date of death
Measured: From date of randomization to death from any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSS/pMMR Type Metastatic Colorectal Adenocarcinoma PatientsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huai'an First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936488
- Sponsor's protocol ID
- HACRC-01
- Status last verified
- Dec 2024
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06936488
- Acronym / sponsor ID
- HACRC-01
- Keywords
- intestinal cancer，Ivonescimab
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Huai'an First People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 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.
A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR Advanced Colorectal Cancer
Main purpose:
Evaluate the efficacy and safety of the combination therapy of Ivonescimab (AK112) and TAS-102 in the treatment of refractory MSS/pMMR advanced colorectal cancer
Exploratory purpose:
Evaluation of the relationship between immune markers, patient efficacy, and prognosis in the treatment of refractory MSS/pMMR advanced colorectal cancer with the combination of Ivonescimab (AK112) and TAS-102 Study endpoint
Primary endpoint:
Researchers evaluated the PFS rate at 18 weeks based on RECIST v1.1.
Secondary endpoint:
ORR, DCR, PFS, and OS evaluated based on RECIST v1.1. The incidence and severity of adverse events (AEs)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab | Experimental | Drug: Ivonescimab,TAS-102 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18 years old and above but 75 years old and below, regardless of gender;
- Previously received at least two standard chemotherapy regimens for advanced colorectal cancer and demonstrated disease progression or intolerance to the last regimen.
- Patients who have received adjuvant/neoadjuvant chemotherapy and experience recurrence during or within 6 months after completion of adjuvant/neoadjuvant chemotherapy can be considered as a chemotherapy regimen for advanced disease;
- There are sufficient tissue specimens that have been tested as pMMR (immunohistochemistry) or MSS (PCR or NGS)
- Have at least one measurable lesion (RECIST v1.1);
Key exclusion criteria (14 listed)
- Previously received TAS-102 treatment.
- Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-CD47 antibodies, anti-SIRP α antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immunotherapy, and any other treatment targeting the immune mechanism of tumor.
- Severe wounds that do not heal, ulcers that do not heal, or fractures that do not heal.
- Known coagulation disorders and bleeding disorders that increase the risk of bleeding.
- Researchers believe that patients are unlikely to comply with oral medication treatment plans or study requirements for scheduled evaluations.
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 |
|---|---|---|
| Ivonescimab,TAS-102Ivonescimab,20mg/kg,i.v.,D1,Q3w TAS-102,35mg/m2,bid,D1-5,Q2W | Drug | Ivonescimab |
Primary outcome
PFS rate at 18 weeks
Time frame: At the end of Cycle 6 (each cycle is 28 days)
The progression free survival rate (PFS) at 18 weeks refers to the proportion of patients who have experienced objective deterioration or progression (including death) of the disease for the first time since the start of treatment, and whose survival time has reached or exceeded 18 weeks
2 secondary outcomes
Overall response rate (ORR)
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Overall survival (OS)
Time frame: From date of randomization to death from any cause, assessed up to 2 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 20 Apr 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivonescimab,TAS-102 in people with MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients, run by Huai'an First People's Hospital at 1 site 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 12 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS rate at 18 weeks (time frame: At the end of Cycle 6 (each cycle is 28 days)). 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 20 Apr 2025.