NCT06949982 Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes
| NCT ID | NCT06949982 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sergey Orlov, MD |
| Condition | Metastatic Colorectal Cancer (mCRC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-03-17 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Provide written informed consent * Age ≥ 18 years * Histologically confirmed diagnosis of colorectal cancer (CRC) with distant metastases. * Presence of mutations in the KRAS or NRAS gene. * Participants must have previously treated for metastatic colorectal cancer and experienced disease progression during receiving at least 2 lines of systemic chemotherapy in combination with antiangiogenic agents. * Patient has previously received oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapeutic agents. Exclusion Criteria: * Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias. * Stroke and/or transient ischemic attack within 6 months prior to screening; * Uncontrolled hypertension * History of previous malignancies except non-melanoma skin cancers, or in situ cervical or breast cancer unless a complete remission was achieved at least 2 years prior to randomization AND no additional therapy is required during the study period. Patients having hepatic involvement of cancer should be excluded as per investigator assessment. * Patients with CNS metastases are eligible only if the metastases are adequately treated. * Absolute neutrophil count (ANC) \<1.5×109/L, platelet count \<100×109/L, or hemoglobin \<9.0 g/dL. * Serum total bilirubin \>1.5 × the upper limit of normal (ULN). Participants with Gilbert syndrome, bilirubin \<2 X ULN, and normal AST/ALT are eligible; * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × ULN; * Serum creatinine \>1.5 × ULN. * History of a thromboembolic event * Presence of any allergic reactions to components of the study drugs * Concomitant medications with a known risk of causing QT prolongation and/or Torsades de Pointes. * Any anti-cancer systemic therapy, radiation therapy * Women who are pregnant or lactating; * Presence of unresolved adverse events of grade 2 or higher toxicity, according to CTCAE v5.0 criteria, from prior therapy (except for alopecia or neurotoxicity grade≤2). * Any other serious or uncontrolled medical disorder, active infection, physical examination finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a patient's ability to comply with the study requirements, substantially increase risk to the patient, or impact the interpretability of study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06949982 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Colorectal Cancer (mCRC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06949982 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06949982 currently recruiting?
Yes, NCT06949982 is actively recruiting participants. Contact the research team at orloff-sv@mail.ru for enrollment information.
Where is the NCT06949982 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06949982 clinical trial?
NCT06949982 is sponsored by Sergey Orlov, MD. The trial plans to enroll 60 participants.
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