Trial reportBMC cancer2025
Efficacy and safety of sintilimab plus bevacizumab and CAPOX as first-line treatment for patients with RAS-mutant, microsatellite stable, metastatic colorectal cancer.
Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06206096 (PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for Patients With RAS-mutant, Microsatellite Stable, Metastatic Colorectal Cancer), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
PD-1 Antibody Plus Bevacizumab and CAPOX as First-line Treatment for Patients With RAS-mutant, Microsatellite Stable, Metastatic Colorectal Cancer: a Prospective, Open-label, Single-arm, Phase II Trial
Who cites it
0 citing papers in PubMed.
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis research aimed to assess the efficacy and safety of combining sintilimab with bevacizumab, oxaliplatin, and capecitabine as a primary therapy for patients with RAS-mutated, microsatellite stable (MSS), and metastatic colorectal cancer (mCRC).
methodsIn this prospective, open-label, single-arm, phase II trial, eligible patients received up to 8 cycles of capecitabine and oxaliplatin/bevacizumab plus sintilimab, followed by maintenance therapy with capecitabine, bevacizumab, and sintilimab every three weeks until disease progression. Treatment response was evaluated every 2 cycles (6 weeks) according to the Response Evaluation Criteria in Solid Tumors version 1.1. The primary endpoint was ORR, while the secondary endpoints included PFS and AEs.
resultsThe efficacy analysis and safety analysis included 33 patients. The overall response rate was 72.7%, and the median PFS in the full analysis set was 12.9 months (95% CI: 7.5-18.3), and median OS was not reached. Patients with liver metastases demonstrated a higher ORR (20/24 [83.3%]) than those without (4/9 [44.4%], p = 0.073), and the median PFS was 14.7 for patients with liver metastases and 9.6 months for those without (HR: 1.05, 95%CI: 0.34-3.24; p = 0.932). Most immune-related AEs had grades 1-2, and immunotherapy was discontinued in 4 patients due to immune-related AEs. No treatment-related deaths occurred during the study.
conclusionsThe therapeutic regimen showed encouraging antitumor effects and a favorable safety profile in patients with RAS mutations, MSS, and mCRC, yielding durable results throughout an extended follow-up duration, irrespective of the presence of liver metastases. This research is of great significance because it addresses the limited treatment options in the field of MSS mCRC patients. By providing new treatment strategies or methods, it brings more hope and choices to patients and offers valuable new insights and research directions to the medical community. CLINICAL
trial registrationClinicalTrials.gov: NCT06206096. Registered on May 26, 2021.
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