NCT06154538

Brief Summary

The goal of this clinical trial is to compare the efficacy and safety of the combination of immune checkpoint inhibitors (ICIs) and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of locally advanced colorectal cancer. The main question aims to answer are: Question 1: Compare the pathological complete response rate between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Question 2: Compare the survival outcomes and safety between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
30mo left

Started Nov 2023

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Nov 2023Nov 2028

Study Start

First participant enrolled

November 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

November 28, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

November 12, 2023

Last Update Submit

November 22, 2025

Conditions

Locally Advanced Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • pCR rate

    pathological complete response rate

    at time of surgery

Secondary Outcomes (4)

  • R0 resection rate

    at time of surgical assessment (after 3 cycles), up to 12 months

  • DFS

    up to 3 years after intervention

  • 3 years DFS rate

    3 years

  • OS

    at 1,2,3 years at follow-up time

Other Outcomes (3)

  • adverse event adverse event rate

    90 days

  • treatment-related adverse event

    90 days

  • serious adverse event

    90 days

Study Arms (2)

ICIs + FOLFOX group

EXPERIMENTAL

Patients in this group will receive ICIs combined with FOLFOX regimen, specifically: ICIs, intravenous infusion, D1; Oxaliplatin (85mg/m2), intravenous infusion, D1; Calcium folinate (400mg/m2), intravenous infusion, D1; 5-FU (400mg/m2), intravenous infusion, D1, then continuous intravenous infusion of 1200mg/(m2·d)×2d (total amount of 2400mg/m2, infusion for 46-48h) every two weeks. Imaging evaluation will be performed after 3 cycles of preoperative treatment. If the disease is resectable, surgery will be performed. If R0 resection is achieved, the preoperative regimen will continue for up to 9 cycles.

Drug: Immune checkpoint inhibitorDrug: FOLFOX regimen

FOLFOX group

ACTIVE COMPARATOR

Patients in this group will undergo FOLFOX chemotherapy regimen, specifically: Oxaliplatin 85 mg/m2 dissolved in 500 ml of 5% glucose solution, intravenous drip, on Day 1, in combination with calcium folinate (400mg/m2), intravenous infusion, on Day 1, and 5-FU (400mg/m2), intravenous infusion, on Day 1, followed by continuous intravenous infusion of 1200mg/(m2·d) for 2 days (total dose of 2400mg/m2, infusion for 46-48 hours), once every 2 weeks. After 3 cycles of preoperative treatment, imaging evaluation will be performed. If the disease is resectable, surgery will be performed. If R0 resection is achieved, the preoperative treatment regimen will be continued after surgery, for a maximum of 9 cycles.

Drug: FOLFOX regimen

Interventions

Immune checkpoint inhibitorDRUG

PD-1 antibody

Also known as: 1
ICIs + FOLFOX group
FOLFOX regimenDRUG

FOLFOX chemotherapy

Also known as: 0
FOLFOX groupICIs + FOLFOX group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75, no gender restrictions;
  • Histologically or cytologically confirmed colorectal adenocarcinoma;
  • Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging);
  • Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing;
  • No prior systemic drug therapy and/or radiotherapy for colorectal adenocarcinoma;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Normal major organ function, no severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency diseases (see protocol for details);
  • Voluntary participation in this study and signed informed consent form;
  • Expected good compliance to complete the study treatment, follow-up for efficacy and adverse reactions according to the protocol requirements.

You may not qualify if:

  • Pathology is other malignant tumors besides adenocarcinoma, such as squamous cell carcinoma, gastrointestinal stromal tumor, melanoma, etc.;
  • Within 5 years prior to the first use of investigational drug, diagnosed with other malignant tumors, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ cervical cancer and/or breast cancer effectively removed;
  • Any distant metastatic colorectal adenocarcinoma (according to AJCC 8th edition staging, determined as M1), including but not limited to distant lymph node metastasis, liver metastasis, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion;
  • Various severe underlying diseases and autoimmune diseases (see protocol for details);
  • Unable to control recurrent bleeding or subjects who received blood transfusion within 2 weeks prior to the first use of investigational drug;
  • Any other circumstances where the investigator believes it may increase the risk associated with participating in the study, the administration of the investigational drug, or affect the subject's ability to receive the investigational drug and the reliability of the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100038, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint InhibitorsFolfox protocol

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Study Officials

  • Qian Liu

    vice director of colorectal surgery dept.

    PRINCIPAL INVESTIGATOR

  • Jing Huang

    vice director of medical oncology dept.

    STUDY DIRECTOR

Central Study Contacts

Qian Liu

CONTACT

+8618610506948fcwpumch@163.com

Xiyue Hu

CONTACT

+8618610506948hxy1101bjmu@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2023

First Posted

December 4, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2028

Last Updated

November 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)