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AzTrials

Colon CancerPhase 2NCT04625803

Neoadjuvant Therapy for Locally Advanced Colon Cancer

A Phase 2 study testing Camrelizumab , apatinib and chemotherapy in people with Colon Cancer and Neoadjuvant Therapy, run by Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colon Cancer, Neoadjuvant Therapy
What is being tested?
Camrelizumab , apatinib and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
4 Jan 2021to 30 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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, ≤75 years
  • Histologically confirmed colon cancer ( tumor penetrated of muscularis propria depth ≥5mm of T3 , T4, N0-2, M0) without distant metastasis (AJCC 8th).
  • ECOG 0-1
  • Surgical treatment is planned after completion of neoadjuvant therapy
  • Patients can swallow pills normally
  • Expected overall survival ≥12 months
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  • Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.
  • AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
  • Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
  • Patients who have not received systemic chemotherapy or immunotherapy
  • Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;
  • Informed consent has been signed.

Who cannot join

  • Patients have received any prior systemic antitumor therapy;
  • Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study).
  • Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed.
  • Certain or suspected distant metastases.
  • The patient has a history of autoimmune disease.
  • Serious uncontrolled systemic diseases, such as severe active infections;
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  • A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive;
  • Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin
  • Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA >500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) may be enrolled
  • Anti-infective therapy was not discontinued 14 days before the study;
  • A prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, and symptomatic interstitial lung disease or the presence of active pneumonia on a chest CT scan within 4 weeks prior to the study.
  • Patients have a history of intestinal obstruction within six months. Patients with incomplete obstruction syndrome of ileus at the time of initial diagnosis may be enrolled in the study if they have received definitive (surgical) treatment to resolve the symptoms, as assessed by the investigator.
  • Patients have non-resectable factors, including surgical contraindications
  • Patients Have high blood pressure that cannot be well controlled by antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg)
  • Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein >1.0g;
  • Known to be allergic to any study drug;
  • Patients have participated in other drug clinical studies within 4 weeks before enrollment;
  • Lactating women
  • According to the judgment of the researcher, the patient may have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First affiliated hospital, Zhejiang University

    Hangzhou, Zhejiang, 310006

Other trials in China

About this study

Official title: Camrelizumab and Apatinib Combined With Chemotherapy (mFOLFOX6) in Neoadjuvant Therapy for Locally Advanced Colon Cancer

To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer.

Read the detailed description

To determine the rate of tumor regression grade 2-4 at time of radical resection of MSS/pMMR colon cancer following neoadjuvant treatment.To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment, pathologic complete response (pCR) rates, R0 resection rate, 2 year Disease free survival, OS(overall survival) and adverse events, including perioperative complication and mortality rate.

To determine the pathologic downstage rates and pCR rate of radical resection of MSI/dMMR colon cancer.

Being tested
Camrelizumab , apatinib and chemotherapy
Keywords
colon cancer, camrelizumab, neoadjuvant therapy, chemotherapy, apatinib
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab , apatinib and chemotherapyDrug

    Camrelizumab 200 mg, IV infusion on Days 1 each 14-day cycle

    Apatinib 250mg oral administration once a day, for two months

    mFOLFOX6 oxaliplatin 85 mg/m^2 IV infusion on Day 1 of each14-day cycle. Fluorouracil: 400 mg/m2 as a bolus injection given after a two-hour leucovorin infusion at a dose of 400 mg/m2. The loading dose is then followed by a 46-hour 5-fluorouracil infusion of 2,400 mg/m2 via a pump programmed to provide a constant drug infusion rate.

Study groups in NCT04625803
Study groupRoleWhat they receive
chemotherapy, PD-1 inhibitor and ApatinibExperimentalParticipants received 5 preoperative cycles of PD-1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD-1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy.
Receives: Drug: Camrelizumab , apatinib and chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor Regression Rate of MSS/pMMR Patients

    the percentage of tumor regression rate (2-4) in pMMR patients

    Measured: 2 years

Secondary outcomes (7)

  1. Pathologic Complete Response (pCR) Rates

    Percentage of patients with pathological complete response

    Measured: 2 years

  2. R0 Resection Rate

    R0 resection accounted for the percentage of all surgical patients=100%

    Measured: 2 years

  3. The Rate of 2 Year Disease Free Survival (DFS)

    Disease-free survival (DFS) is defined as the time from operation to recurrence of tumor or death. We will evaluate 2 year DFS is 100%

    Measured: 2 years

  4. Overall Survival (OS)

    Refers to the time of death from enrollment to any cause

    Measured: 2 years

  5. Event Free Survival (EFS)

    The period from the beginning of neoadjuvant therapy to the occurrence of any of the following events, whichever occurs first: tumor progression as assessed by RECIST 1.1; Tumor recurrence, including local recurrence or distant metastasis; Death from any cause; EFS=100%

    Measured: 2 years

  6. Perioperative Complication Rate

    The complication rate of all patients during the period around the time of a surgical operation

    Measured: 3 months

  7. Mortality Rate

    the ratio between deaths and all patients in the study during treatment

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start4 Jan 2021
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

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
Model description
MSS/pMMR:Participants received 5 preoperative cycles of PD1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy. MSI/dMMR:Participants received 5 preoperative cycles of PD1 inhibitor and 2 months of apatinib, followed by surgery. Apatinib,PD1 inhibitor needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of PD-1 monoclonal antibody and apatinib were performed as adjuvant therapy.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04625803
Sponsor's protocol ID
AMBITION
Status last verified
May 2025
First submitted
4 Nov 2020
Last updated
17 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tong Z, Gao L, Wang D, Zhao P, Bao X, Zhang H, Dai X, Liu L, Zhu X, Gao Y, Zheng Y, Fu Q, Liu F, Chen W, Xu X, Fang W. Neoadjuvant mFOLFOX6 plus camrelizumab and apatinib in colon cancer and biomarker research via spatiotemporal-omics profiling. NPJ Precis Oncol. 2026 Apr 1;10(1):192. doi: 10.1038/s41698-026-01387-0.

    PubMed 41922688

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab , apatinib and chemotherapy in people with Colon Cancer and Neoadjuvant Therapy, run by Zhejiang University 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 19 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: finished, as of the sponsor's last update on 17 Jun 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.

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?

Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tumor Regression Rate of MSS/pMMR Patients (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04625803, which also lists 1 linked publication.

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 Jun 2025.

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