Colon CancerPhase 2NCT06790212
Neoadjuvant CAPOX Plus Ivonescimab Versus CAPOX for Locally Advanced Colon Cancer
A Phase 2 study testing Ivonescimab, Oxaliplatin and Capecitabine in people with Colon Cancer, run by Sun Yat-sen University.
Trial summary
Neoadjuvant chemotherapy has been validated by several clinical studies to achieve preoperative downstaging and improve survival outcomes in patients with locally advanced colon cancer . Enhancing the efficacy of neoadjuvant treatment further represents a crucial direction for future research. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Ivonescimab, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2025to 30 Jun 2028
- 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
- Histologically confirmed locally advanced resectable colon adenocarcinoma (colon cancer located more than 12 cm from the anal verge);
- Imaging staging is T4, or T3 (with invasion of the muscularis propria ≥5 mm) combined with at least one of the following risk factors: number of metastatic lymph nodes ≥1, extramural vascular invasion (EMVI+), involvement of the mesocolic fascia. (TNM clinical staging (cTNN) according to the 8th edition of AJCC/UICC guidelines);
- No distant metastasis;
- At least one measurable lesion ;
- Immunohistochemical testing of endoscopic biopsy samples by the study center's pathology department confirms diagnosis as pMMR, or genetic testing confirms MSS/MSS-L status (by PCR or NGS method);
- No prior anti-tumor treatment for colorectal cancer;
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- Age ≥18 years and ≤75 years, regardless of gender;
- ECOG performance status score 0-1;
- Signed written informed consent before enrollment;
- Expected survival of more than 12 weeks;
- Adequate organ and bone marrow function.
Who cannot join
- History of allergic diseases, severe drug allergies, or known allergy to large molecular weight protein formulations or Ivonesimab;
- Cardiopulmonary insufficiency or hepatic and renal insufficiency that cannot tolerate CAPOX chemotherapy, known allergies to oxaliplatin, capecitabine, irinotecan;
- Presence of distant metastases;
- Incomplete or complete bowel obstruction; however, patients can be enrolled if the obstruction is relieved by conservative treatment, intestinal stenting, or colostomy;
- History of significant bleeding tendency or coagulation disorders;
- Any of the following complications:
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- Major gastrointestinal hemorrhage, perforation
- Symptomatic cardiac disease (including unstable angina, myocardial infarction, and heart failure)
- Uncontrolled diabetes and hypertension
- Uncontrolled diarrhea (despite adequate treatment, it still interferes with daily activities)
- Patients who are using immunosuppressants, systemic, or absorbable topical steroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), and continue to use them within 2 weeks before enrollment;
- History of uncontrolled cardiac symptoms or diseases;
- Previous history of thyroid dysfunction that cannot be maintained within normal range despite medication;
- Use of traditional Chinese medicine immune modulators within 2 weeks before official treatment, or received systemic chemotherapy, immunotherapy, biological therapy, or other anti-tumor treatments including traditional Chinese medicine within 4 weeks prior to enrollment;
- Previous exposure to immunotherapy, including immune checkpoint inhibitors, immune cell therapy, or any treatment targeting tumor immune mechanisms;
- Previous exposure to systemic bevacizumab or its biosimilars;
- Active infection or unexplained fever >38.5°C during screening or before the first dose (patients with fever due to tumor, as determined by the investigator, may be eligible);
- Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, active tuberculosis, or severely impaired lung function;
- Congenital or acquired immunodeficiency (such as HIV-infected individuals, HIV 1/2 antibody positive);
- For patients with positive acute or chronic active hepatitis B, HBV DNA testing must be performed. If the HBV DNA copy number ≤2×10^3 copies/mL or ≤400 IU/mL or below the limit of detection, they may enroll. HBsAg (+) patients should receive antiviral therapy throughout the study period to prevent viral reactivation. For patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic antiviral therapy is not required but close monitoring for viral reactivation is necessary;
- Acute or chronic active hepatitis C (HCV), defined as HCV antibody positive and HCV RNA levels above the limit of detection;
- Vaccination with live vaccines less than 4 weeks before the start of study medication or likely to occur during the study period;
- Known history of psychotropic drug abuse, alcoholism, or drug addiction;
- Pregnant or breastfeeding women, and men and women unwilling to use contraception.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized Phase II Study Evaluating CAPOX Combined with Ivonescimab (a PD-1/VEGF-A Bispecific Antibody) Versus CAPOX Alone As Neoadjuvant Therapy in Patients with Locally Advanced Colon Cancer.
Neoadjuvant chemotherapy has been validated by several clinical studies to achieve preoperative downstaging and improve survival outcomes in patients with locally advanced colon cancer . Enhancing the efficacy of neoadjuvant treatment further represents a crucial direction for future research.
Recognizing the potential of synergistic effects between immunotherapy and anti-angiogenic therapy, the investigators conducted the present randomized study to explore whether Ivonescimab （a PD-1/VEGF bispecific-antibody）combined with neoadjuvant chemotherapy in locally advanced colon cancer could potentially further improve treatment outcomes.
Read the detailed description
This phase II, prospective, randomized controlled trial aims to evaluate the efficacy and safety of combining CAPOX chemotherapy with Ivonescimab, a PD-1/VEGF-A bispecific antibody, compared to neoadjuvant CAPOX therapy alone in patients with high-risk recurrent MSS/pMMR-type colon cancer.
- Conditions
- Colon Cancer
- Being tested
- Ivonescimab, Oxaliplatin, Capecitabine
- Keywords
- neoadjuvent chemotherapy, CAPOX, AK112, Ivonescimab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvonescimabDrug
Also called AK112
20mg/kg Q3W，D1
OxaliplatinDrug
Oxaliplatin，130mg/m2，D1，Q3W；
CapecitabineDrug
Capecitabine，1000mg/m2，po，BID，D1-D14，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant AK112 combined with chemotherapy | Experimental | Three cycles of neoadjuvant treatment with CAPOX plus Ivonescimab, followed by radical surgery 4 to 5 weeks after the last oxaliplatin dose. Receives: Drug: Ivonescimab; Drug: Oxaliplatin; Drug: Capecitabine |
| Neoadjuvant chemotherapy | Active comparator | Three cycles of neoadjuvant CAPOX treatment, followed by radical surgery 4 to 5 weeks after the last dose of oxaliplatin. Receives: Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR rate
In the primary tumor (PT), ≤10% residual viable tumor (RVT).
Measured: though 12 weeks neoadjuvant treatment，after surgery completed
Secondary outcomes (4)
Pathologic complete response，pCR
Pathological complete response will be made based on assessment of the surgical specimen at the primary treatment site，the absence of any viable tumor cells in the resected primary tumor specimen and all regional lymph node samples.
Measured: though 12 weeks neoadjuvant treatment，after surgery completed
R0 resection rate
Complete resection of the tumor with negative margins, meaning no residual tumor is present microscopically.
Measured: after surgery completed，up to 1 month
Disease free survival
Defined as the time from randomization to relapse or death, whichever occurred first
Measured: 2 years
Adverse event (AE)
The severity of AE and the laboratory findings were graded by the investigators according to Common Terminology Criteria for Adverse Events, version 4. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start28 Apr 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Rong Ding, Sun Yat-sen University
- Investigators
- Peirong Ding, MD，phD, Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790212
- Sponsor's protocol ID
- 2025-IIT-0112
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2025
- Last updated
- 17 Mar 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Phase II Study Evaluating CAPOX Combined with Ivonescimab (a PD-1/VEGF-A Bispecific Antibody) Versus CAPOX Alone As Neoadjuvant Therapy in Patients with Locally Advanced Colon Cancer.
- ClinicalTrials.gov ID
- NCT06790212
- Acronym / sponsor ID
- 2025-IIT-0112
- Conditions
- Colon Cancer
- Keywords
- neoadjuvent chemotherapy, CAPOX, AK112, Ivonescimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Jan 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.
Neoadjuvant chemotherapy has been validated by several clinical studies to achieve preoperative downstaging and improve survival outcomes in patients with locally advanced colon cancer . Enhancing the efficacy of neoadjuvant treatment further represents a crucial direction for future research.
Recognizing the potential of synergistic effects between immunotherapy and anti-angiogenic therapy, the investigators conducted the present randomized study to explore whether Ivonescimab （a PD-1/VEGF bispecific-antibody）combined with neoadjuvant chemotherapy in locally advanced colon cancer could potentially further improve treatment outcomes.
Detailed description
This phase II, prospective, randomized controlled trial aims to evaluate the efficacy and safety of combining CAPOX chemotherapy with Ivonescimab, a PD-1/VEGF-A bispecific antibody, compared to neoadjuvant CAPOX therapy alone in patients with high-risk recurrent MSS/pMMR-type colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant AK112 combined with chemotherapy | Experimental | Drug: Ivonescimab, Drug: Oxaliplatin, Drug: CapecitabineThree cycles of neoadjuvant treatment with CAPOX plus Ivonescimab, followed by radical surgery 4 to 5 weeks after the last oxaliplatin dose. |
| Neoadjuvant chemotherapy | Active comparator | Drug: Oxaliplatin, Drug: CapecitabineThree cycles of neoadjuvant CAPOX treatment, followed by radical surgery 4 to 5 weeks after the last dose of oxaliplatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed locally advanced resectable colon adenocarcinoma (colon cancer located more than 12 cm from the anal verge);
- Imaging staging is T4, or T3 (with invasion of the muscularis propria ≥5 mm) combined with at least one of the following risk factors: number of metastatic lymph nodes ≥1, extramural vascular invasion (EMVI+), involvement of the mesocolic fascia. (TNM clinical staging (cTNN) according to the 8th edition of AJCC/UICC guidelines);
- No distant metastasis;
- At least one measurable lesion ;
- Immunohistochemical testing of endoscopic biopsy samples by the study center's pathology department confirms diagnosis as pMMR, or genetic testing confirms MSS/MSS-L status (by PCR or NGS method);
Key exclusion criteria (24 listed)
- History of allergic diseases, severe drug allergies, or known allergy to large molecular weight protein formulations or Ivonesimab;
- Cardiopulmonary insufficiency or hepatic and renal insufficiency that cannot tolerate CAPOX chemotherapy, known allergies to oxaliplatin, capecitabine, irinotecan;
- Presence of distant metastases;
- Incomplete or complete bowel obstruction; however, patients can be enrolled if the obstruction is relieved by conservative treatment, intestinal stenting, or colostomy;
- History of significant bleeding tendency or coagulation disorders;
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 |
|---|---|---|
| IvonescimabAlso: AK11220mg/kg Q3W，D1 | Drug | Neoadjuvant AK112 combined with chemotherapy |
| OxaliplatinOxaliplatin，130mg/m2，D1，Q3W； | Drug | Neoadjuvant AK112 combined with chemotherapy, Neoadjuvant chemotherapy |
| CapecitabineCapecitabine，1000mg/m2，po，BID，D1-D14，Q3W | Drug | Neoadjuvant AK112 combined with chemotherapy, Neoadjuvant chemotherapy |
Primary outcome
MPR rate
Time frame: though 12 weeks neoadjuvant treatment，after surgery completed
In the primary tumor (PT), ≤10% residual viable tumor (RVT).
4 secondary outcomes
Pathologic complete response，pCR
Time frame: though 12 weeks neoadjuvant treatment，after surgery completed
R0 resection rate
Time frame: after surgery completed，up to 1 month
Disease free survival
Time frame: 2 years
Adverse event (AE)
Time frame: up to 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 17 Mar 2025.
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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.
Peirong Ding, MD，phD study chair
Sun Yat-Sen University Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab, Oxaliplatin and Capecitabine in people with Colon Cancer, run by Sun Yat-sen University.
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 11 inclusion and 24 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: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Peirong Ding, MD, Ph D (00862087343124, dingpr@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR rate (time frame: though 12 weeks neoadjuvant treatment，after surgery completed). 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 17 Mar 2025.