Clinical Trial Finder

Comments

Trial in China. Despite mentioning “CRC”, trial seems to be only for unresectable rectal  MSS with KRAS mutations (KRAS wild not addmited).
For patients who have not received systemic treatment yet, and have lower edge of the lesion located ≥12 cm from the anal verge.

Trials seems to use SBRT ablation (a very focused radiotherapy) instead of surgery, over the main tumor, and later capecitabine + Oxaliplatin (CAPEOX) + Bevacizumab (standard of care), with the addition of anti PD-1 immunotherapy (tislelizumab).

Contacts

Inclusion Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria

Exclusion Criteria:

* 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).
* Patients with any active autoimmune diseases or a history of requiring steroid or immunotherapy treatment.
* Complex situations with concurrent active bleeding, perforation, or requiring emergency surgery.
* Have received systemic anti-cancer treatment for rectal cancer.
* 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).
* 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).
* Pregnant or lactating women.
* 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