NCT04625803

Neoadjuvant Therapy for Locally Advanced Colon Cancer

Completed Phase 2 Results posted Last updated 17 June 2025

What this trial tests

Phase 2 trial testing Camrelizumab , apatinib and chemotherapy in Colon Cancer in 64 participants. Completed in 30 September 2023.

Timeline

4 January 2021

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	Zhejiang University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	4 January 2021
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across China

Drugs / interventions tested

• Camrelizumab , apatinib and chemotherapy — full drug profile →

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Zhejiang University

Who can join

Adults 18 to 75, any sex, with Colon Cancer or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tumor Regression Rate of MSS/pMMR Patients Primary · 2 years

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

Group	Value	95% CI
Tumor Regression Grade Rate of pMMR Patients	7

Mortality Rate Secondary · 2 years

the ratio between deaths and all patients in the study during treatment

Group	Value	95% CI
Mortality Rate	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Neutropenia

Serious: 10/12 (83%)

Deaths: 0/12

Serious adverse events (5 terms)

Reaction	System	Neutropenia
neutropenia	Blood and lymphatic system disorders	—
decreased white blood cell count	Blood and lymphatic system disorders	—
thrombocytopenia	Blood and lymphatic system disorders	—
hypertension	Blood and lymphatic system disorders	—
ALT increased	Blood and lymphatic system disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Neutropenia
RCCEP	Cardiac disorders	—
Vomiting	Gastrointestinal disorders	—
Hypertension	Cardiac disorders	—

Most-reported serious reactions: neutropenia, decreased white blood cell count, thrombocytopenia, hypertension, ALT increased.

Data from ClinicalTrials.gov NCT04625803 adverse events section.

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?
   Zhu J, Lian J, Xu B, Pang X, et al · · 2023 · cited 38× · PMID 36949951 · DOI 10.3389/fimmu.2023.1120684
2. Immunotherapy in the neoadjuvant treatment of gastrointestinal tumors: is the time ripe?
   Gervaso L, Ciardiello D, Oliveira RA, Borghesani M, et al · · 2024 · cited 12× · PMID 38782539 · DOI 10.1136/jitc-2023-008027
3. Preoperative Strategies for Locally Advanced Colon Cancer.
   Nair KG, Kamath SD, Chowattukunnel N, Krishnamurthi SS. · · 2024 · cited 5× · PMID 38349502 · DOI 10.1007/s11864-024-01184-6
4. Role of neoadjuvant therapies in locally advanced colon cancer.
   Castria TB, Lenz G, Valagni G, Kim RD. · · 2025 · cited 1× · PMID 40736234 · DOI 10.1097/cm9.0000000000003756
5. Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
   Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728
6. Neoadjuvant mFOLFOX6 plus camrelizumab and apatinib in colon cancer and biomarker research via spatiotemporal-omics profiling.
   Tong Z, Gao L, Wang D, Zhao P, et al · · 2026 · PMID 41922688 · DOI 10.1038/s41698-026-01387-0