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

NCT06470178 | Not Yet Recruiting

• 1 other identifier: HMPL-013-C2-CRC09
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Fruquintinib; anti-angiogenic targeted therapies; colorectal cancer; neoadjuvant therapy; conversion therapy

Outcome Measures

Primary Outcomes (2)

• Corhot1: Pathological Complete Response Rate (pCR)

  Pathological Complete Response Rate (pCR), defined as no residual tumor cells in the surgical specimen of the primary tumor and lymph nodes (ypT0N0); corresponds to TRG grade 0.

  Time from the first treatment up to 12 weeks

• Corhot2: R0 surgical conversion rate

  R0 surgical conversion rate：The proportion of subjects who achieve complete R0 resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.

  Time from the first treatment up to 24 weeks

Secondary Outcomes (10)

• Corhot1: R0 resection rate

  Time from the first treatment up to 12 weeks

• Corhot1: Event-Free Survival (EFS)

  Time from the first treatment up to 2 years

• Corhot1: 1-year Event-Free Survival (EFS) rate

  Time from the first treatment up to 12 months.

• Corhot1 and Corhot2: Overall Survival (OS)

  Time from the first treatment up to 2 years.

• Corhot1 and Corhot2: 1-year Overall Survival (OS) rate

  Time from the first treatment up to 12 months.

Study Arms (2)

Cohort 1 : neoadjuvant treatment

Combination Product: corhot1: chemotherapy combined with fruquintinib

Cohort 2:conversion treatment

Combination Product: corhot2: chemotherapy combined with fruquintinib

Interventions

corhot1: chemotherapy combined with fruquintinib COMBINATION_PRODUCT

Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: mFOLFOX6 or CAPEOX. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.

Cohort 1 : neoadjuvant treatment

corhot2: chemotherapy combined with fruquintinib COMBINATION_PRODUCT

Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: mFOLFOX6 or CAPEOX. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.

Cohort 2:conversion treatment

Eligibility Criteria

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

Study Population

Colorectal cancer who have received chemotherapy and fruquintinib as neoadjuvant or conversion treatment.

You may qualify if:

• Patients must meet all of the following criteria to be enrolled in this study:
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 before treatment.
• Expected survival time of \>6 months before neoadjuvant therapy and \>3 months before conversion therapy.
• No significant organ dysfunction or drug contraindications before receiving neoadjuvant or conversion therapy.
• There is no mandatory requirement for target lesions. Objective response rate (ORR) assessment is based on all evaluable patients, regardless of the presence of target lesions. For patients without target lesions, those assessed as non PR/non PD will be analyzed as stable disease (SD).

You may not qualify if:

• Patients meeting any of the following criteria are not eligible to enter the study:
• 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.
• Use of non-study drug treatments during the study period that may interfere with the analysis.
• Patients who did not undergo any tumor efficacy assessment after receiving neoadjuvant or conversion therapy.
• Less than 2 cycles of fruquintinib neoadjuvant or conversion therapy.
• Patients with insufficient follow-up information as judged by the investigator (such as not returning to the hospital for treatment or efficacy assessment after initial treatment).

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

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

Study Officials

• Bin Xiong, doctor

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChunWei Peng, doctor

CONTACT

13476196566; whupengcw@whu.edu.cn

Bin Xiong, doctor

CONTACT

13886029351; binxiong1961@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: May 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)