Phase 2
N=64
Neoadjuvant Therapy for Locally Advanced Colon Cancer
Colon Cancer · Neoadjuvant Therapy
Bottom Line
View on ClinicalTrials.gov: NCT04625803 ↗Enrolled (actual)
64
Serious AEs
83.3%
Results posted
Jun 2025
Primary outcome: Primary: Tumor Regression Rate of MSS/pMMR Patients — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Camrelizumab , apatinib and chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zhejiang University
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Regression Rate of MSS/pMMR Patients |
7 | — |
| SECONDARY Pathologic Complete Response (pCR) Rates |
— | — |
| SECONDARY R0 Resection Rate |
— | — |
| SECONDARY The Rate of 2 Year Disease Free Survival (DFS) |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Event Free Survival (EFS) |
— | — |
| SECONDARY Perioperative Complication Rate |
— | — |
| SECONDARY Mortality Rate |
— | — |
Summary
To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer.
Eligibility Criteria
Inclusion Criteria
- 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
- 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 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;
- 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 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.
Data sourced from ClinicalTrials.gov (NCT04625803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.