Authorised Therapeutic exploratory (Phase II) Stage IV colorectal cancer patients with no evidence of disease (NED)

Adjuvant therapy in stage IV colorectal cancer patients NED

EU CTIS ID: 2024-518217-26-00

What this study is testing

Disease Free Survival (DFS)

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • ≥ 18 years
  • Histologically confirmed diagnosis of colorectal adenocarcinoma
  • Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy
  • NED state ascertained by means of CT scan and/or PET scan and/or MRI scan
  • Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment or those who achieved complete response on systemic therapies are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle

You likely can't join if

  • Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
  • Patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficiency (dMMR) are not allowed
  • Any form of systemic disease that, in the opinion of the Investigator, would make the subject unsuitable for the study (including autoimmunity) or would prevent compliance with the study protocol
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.