Combining hydroxychloroquine with chemotherapy for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of a combination treatment involving hydroxychloroquine, methotrexate, capecitabine, and bevacizumab compared to regorafenib in patients with refractory metastatic colorectal cancer harboring RAS mutations. The research aims to determine if this combination can prolong progression-free and overall survival, as well as improve response rates and disease control. The approach is based on the understanding that hydroxychloroquine can inhibit autophagy, a mechanism that allows cancer cells to survive under stress, thereby enhancing the effectiveness of chemotherapy. Participants will be closely monitored for safety and treatment outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Pavlov State Medical University
  Saint Petersburg, Sankt-Peterburg, Russia Recruiting

Study contacts

• Study coordinator: Sergey V. Orlov, Professor
• Email: orloff-sv@mail.ru
• Phone: +79811957915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.