Neoadjuvant Therapy for Locally Advanced Colon Cancer

NCT04625803 | Completed Phase 2 Results

• 1 other identifier: AMBITION
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colon Cancer; Neoadjuvant Therapy

Keywords

colon cancer; camrelizumab; neoadjuvant therapy; chemotherapy; apatinib

Outcome Measures

Primary Outcomes (1)

• Tumor Regression Rate of MSS/pMMR Patients

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

  2 years

Secondary Outcomes (7)

• Pathologic Complete Response (pCR) Rates

  2 years

• R0 Resection Rate

  2 years

• The Rate of 2 Year Disease Free Survival (DFS)

  2 years

• Overall Survival (OS)

  2 years

• Event Free Survival (EFS)

  2 years

Study Arms (1)

chemotherapy, PD-1 inhibitor and Apatinib

EXPERIMENTAL

Participants 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.

Drug: Camrelizumab , apatinib and chemotherapy

Interventions

Camrelizumab , apatinib and chemotherapy DRUG

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.

chemotherapy, PD-1 inhibitor and Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\<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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

camrelizumab; apatinib; Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Weijia Fang
• Organization: The First Affiliated Hospital, Zhejiang University School of Medicine

weijiafang@zju.edu.cn

+86 87235147

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 12, 2020
• Study Start: January 4, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-05

Locations

CN (1)