NCT06949982: x-МАР

A Randomized Trial To Compare Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Versus Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes

Recruiting now Phase 2 Last updated 30 April 2025

What this trial tests

Phase 2 trial testing experimental group x-MAP in Metastatic Colorectal Cancer (mCRC) in 60 participants. Currently enrolling.

Timeline

17 March 2025

Primary endpoint
1 April 2027

1 October 2027

Quick facts

Lead sponsor	Sergey Orlov, MD
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	17 March 2025
Primary completion	1 April 2027
Estimated completion	1 October 2027
Sites	1 location across Russia

Drugs / interventions tested

• experimental group x-MAP
• Regorafenib (BAY 73-4506) — full drug profile →

Conditions studied

• Metastatic Colorectal Cancer (mCRC) — all drugs for Metastatic Colorectal Cancer (mCRC) →
• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →

Sponsor

Sergey Orlov, MD

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer (mCRC) or Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  Time frame: From randomization until the first documentation of best overall response (up to 24 months)
  objective response rate (ORR) was defined as the proportion of participants whose best overall outcome included a confirmed complete response (CR) or partial response (PR), assessed by the investigator using RECIST version 1.1 criteria. PR corresponds to a minimum 30% reduction in the total diameter of target lesions compared to the baseline measurements. CR indicates the total disappearance of al
• Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  Time frame: From randomization until the first documentation of objective progression or death, whichever comes first (up to 24 months)
  Progression-free survival (PFS) was defined as the time from randomization to the initial occurrence of documented disease progression (PD) or death from any cause, whichever occurs earlier. According to RECIST 1.1 criteria, PD was characterized by at least a 20% enlargement in the total diameter of target lesions compared to the smallest sum recorded during the study, along with an absolute incre

Sponsor's own description

This study will evaluate efficacy and safety of hydroxychloroquine combined with methotrexate, capecitabine and bevacizumab versus regorafenib in participants with refractory metastatic colorectal cancer with mutations in KRAS or NRAS genes. The hypotheses of this study are that a combination of hydroxychloroquine, methotrexate, capecitabine, and bevacizumab (compared to regorafenib) prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.

Publications & conference data

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

1. The autophagy-senescence axis as a threshold model of aging and therapeutic targeting.
   Bahar ME, Hwang JS, Lai TH, Akter KM, et al · · 2026 · cited 2× · PMID 41690118 · DOI 10.1016/j.redox.2026.104079
2. Targeted Therapies and Pharmacologic Advances in Mucous Membrane Pemphigoid: A Comprehensive Review.
   Busol VN, Kudryashov NV. · · 2025 · PMID 41236290 · DOI 10.5826/dpc.1504a5749