A Real-World Study of Neoadjuvant/Conversion Therapy for Colorectal Cancer With Chemotherapy And Anti-Angiogenic Targeted Agents

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWuhan University

About this trial

Fruquintinib is already the standard third-line treatment for metastatic colorectal cancer, but the efficacy of fruquintinib in neoadjuvant and conversion therapy for locally advanced/advanced colorectal cancer has not yet been reported. This study aims to observe the efficacy and safety of fruquintinib combined with chemotherapy in neoadjuvant or conversion therapy for colorectal cancer patients in the real world.

Eligibility criteria

Qualifiers

Age ≥18 years and ≤75 years;

Either gender;

Patients with histologically confirmed colorectal cancer. For the neoadjuvant treatment cohort: Rectal cancer is limited to high rectal cancer, but patients with mid to low rectal cancer who are unwilling or unsuitable for neoadjuvant chemoradiotherapy can also be included.

Neoadjuvant treatment cohort: Clinically staged as stage II (T3-4N0M0) or stage III (T1-4N1-2M0) and initially resectable; patients with clinical stage M1 but initially resectable can also be included in the neoadjuvant treatment cohort, such as patients with stage IV liver oligometastasis. Conversion treatment cohort: Patients with initially unresectable but potentially resectable locally advanced or advanced distant metastatic colorectal cancer (according to AJCC 8th), and patients with locally advanced low rectal cancer who are unsuitable or unwilling to undergo chemoradiotherapy can also be included.

Disqualifiers

History of other primary malignant tumors, except: (1) complete remission of malignant tumors at least 2 years before enrollment and no need for other treatment during the study period; (2) adequately treated non-melanoma skin cancer or malignant melanoma without evidence of disease recurrence; (3) adequately treated in situ carcinoma.

dMMR/MSI-H.

Female patients who are pregnant or lactating.

Known allergy (Grade 3 or higher allergic reaction) or contraindication to anti-angiogenic drugs or chemotherapy drug components.

Trial design

Treatments tested in this trial

  • corhot1: chemotherapy combined with fruquintinib
  • corhot2: chemotherapy combined with fruquintinib

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators