NCT06823323: MSSpMMRCapeOX

The Study on the Efficacy and Safety of Lactobacillus Johnsonii in Combination with CapeOX and Pembrolizumab for the Treatment of MSS/pMMR Metastatic Colorectal Cancer.

Not yet recruiting NA Last updated 12 February 2025

What this trial tests

NA trial testing Lactobacillus johnsonii in Metastatic Colorectal Cancer (CRC) in 150 participants. Not yet recruiting.

Timeline

1 March 2025

Primary endpoint
1 March 2026

1 June 2026

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	1 March 2025
Primary completion	1 March 2026
Estimated completion	1 June 2026

Drugs / interventions tested

• Lactobacillus johnsonii
• Placebo

Conditions studied

• Metastatic Colorectal Cancer (CRC) — all drugs for Metastatic Colorectal Cancer (CRC) →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 75, any sex, with Metastatic Colorectal Cancer (CRC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to verify the effectiveness and safety of Lactobacillus johnsonii in combination with CapeOX and Pembrolizumab for the treatment of MSS/pMMR metastatic colorectal cancer (CRC). The main questions it aims to answer are:

① To verify the effectiveness of Lactobacillus johnsonii in the treatment of MSS/pMMR type metastatic colorectal cancer (mCRC) who have failed the standard regimen of chemotherapy;

② To explore the safety of Lactobacillus johnsonii in the treatment of MSS/pMMR type metastatic colorectal cancer (mCRC) who have failed the standard regimen of chemotherapy.

Participants who meet all the inclusion criteria will be enrolled in the study and randomly assigned in a 1:1 ratio to either the CapeOX + Pembrolizumab + placebo group or the CapeOX + Pembrolizumab + Lactobacillus johnsonii group.

Publications & conference data

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

1. The gut microbiota in cancer immunity and immunotherapy.
   Xie M, Li X, Lau HC, Yu J. · · 2025 · cited 20× · PMID 40770084 · DOI 10.1038/s41423-025-01326-2
2. Microbiota-centered interventions to boost immune checkpoint blockade therapies.
   Almonte AA, Thomas S, Zitvogel L. · · 2025 · cited 12× · PMID 40261296 · DOI 10.1084/jem.20250378
3. Intratumoral microbiota in cancer: molecular mechanism and therapeutic strategies.
   Yu Y, Guo Z, Luo Z, Dian Y, et al · · 2026 · PMID 42171956 · DOI 10.1186/s43556-026-00473-w
4. Gut microbiota drives cancer evolution and therapy resistance.
   Min S, Zhang Y, Zhang H, Liu Q. · · 2026 · PMID 41527087 · DOI 10.1186/s12943-025-02564-8
5. Harnessing Single-Cell RNA-Seq for Computational Drug Repurposing in Cancer Immunotherapy.
   Cheng OJ, Tran TTT, Chen YA, Tan AC. · · 2025 · PMID 41305010 · DOI 10.3390/ph18111769