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NCT06835179Not yet recruitingPhase 2

SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.

Evaluation of the Efficacy and Safety of SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, MSS-Type, and Unresectable Metastatic Colorectal Cancer: a Single-center, Single-arm, Open-label Clinical Trail.

Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

SBRT Combined with CAPEOX, Bevacizumab, and PD-1 Inhibitor in RAS-Mutant, Microsatellite Stable (MSS), Unresectable Metastatic Colorectal Cancer (mCRC): a Single-center, Single-arm, Open-label Clinical Trail

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
28 (estimated)
First submitted
11 Feb 2025
Start date
Feb 2025
Primary completion date
Feb 2027
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06835179

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 28
  • From Feb 2025 to the primary completion date, Feb 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Complex situations with concurrent active bleeding, perforation, or requiring emergency surgery.
  • Have received systemic anti-cancer treatment for rectal cancer.
  • Any grade 2 or above toxic reactions (classified according to the Common Terminology Criteria for Adverse Events (CTCAE) 5th edition) caused by previous treatment that have not subsided (excluding anemia, hair loss, and skin pigmentation).

Other illness

  • Patients with any active autoimmune diseases or a history of requiring steroid or immunotherapy treatment.
  • Simultaneously present with other non colorectal cancer tumor diseases.
  • Patients with interstitial lung disease, non infectious pneumonia or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
  • Patients who are known or have been tested for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  • Known or suspected history of allergies to any relevant drugs used in the trial

Lab values

  • Patients who have received antibodies against programmed death receptor-1 (PD-1) or its ligand (PD-L1), as well as antibodies against cytotoxic T lymphocyte associated antigen 4 (CTLA-4).

Other

  • Pregnant or lactating women.

Who the study is looking for

  • Aged 18-75 years, regardless of gender.
  • Lower edge of the lesion located ≥12 cm from the anal verge.
  • Histologically confirmed colorectal adenocarcinoma.
  • Confirmed as unresectable by multidisciplinary team (MDT) evaluation.
  • RAS mutation-positive.
  • Microsatellite/mismatch repair status: MSS/pMMR.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival ≥3 months.
  • Adequate hematological, hepatic, and renal function:
    • Neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥75 × 10⁹/L; Serum total bilirubin ≤1.5 × upper normal limit (UNL); Aspartate aminotransferase (AST) ≤2.5 × UNL; Alanine aminotransferase (ALT) ≤2.5 × UNL; Serum creatinine ≤1.5 × UNL.
  • Karnofsky Performance Status (KPS) score ≥70.
  • Adequate organ function with no contraindications to surgery, radiotherapy, chemotherapy, or immunotherapy.
  • No prior chemotherapy or other antitumor therapy before enrollment.
  • No prior immunotherapy received.
  • Willingness and ability to comply with the study protocol during the trial period.
  • Signed written informed consent.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.