Trial reportNature communications2025
Regorafenib plus sintilimab as a salvage treatment for microsatellite stable metastatic colorectal cancer: a single-arm, open-label, phase II clinical trial.
Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04745130 (Efficacy and Safety of Sintilimab Combined With Regorafenib and Cetuximab / Sintilimab Combined With Regorafenib in Posterior Line Therapy of Advanced Colorectal Cancer), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Efficacy and Safety of Sintilimab Combined With Regorafenib and Cetuximab / Sintilimab Combined With Regorafenib in Posterior Line Therapy of Advanced Colorectal Cancer (Regosinti)
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A network meta-analysis of endocrine adverse events induced by immune checkpoint inhibitors in colorectal cancer.Frontiers in immunology · 2026Pooled it
- Review
- Review
- Apatinib enhances anti-PD-1 efficacy by inhibiting Exo70-mediated exosome secretion in pMMR/MSS colorectal cancer.NPJ precision oncology · 2026Article
- Pathological Complete Response in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Following Conversion Therapy With TACE, HAIC, Lenvatinib, and Sintilimab: A Case Report.Clinical case reports · 2026Article
- Immunotherapy-based treatment patterns and clinical outcomes across lines of therapy in microsatellite stable metastatic colorectal cancer: A real-world study.Oncology letters · 2026Article
- The Molecular Signature of Early-Onset Colorectal Cancer Liver Metastases: Distinct Biology and Clinical Challenges.International journal of molecular sciences · 2026Review
- Unraveling regorafenib resistance: metabolic reprogramming, tumor plasticity, and novel approaches to overcome therapy failure.Archives of pharmacal research · 2026Review
- Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.Molecular biomedicine · 2026Review
- Immune checkpoint inhibitor in third-line treatment of microsatellite stable metastatic colorectal cancer: an observational and retrospective study.BMC cancer · 2026Observational
- Molecular profiling-directed individualized adjuvant therapy in colorectal cancer: Bridging consensus guidelines to clinical disparities.World journal of gastroenterology · 2026Review
- Over and above what is visible and conventional: development of new territories in colorectal cancer management.Annals of coloproctology · 2026Article
- Exploring research frontiers and emerging trends of tyrosine kinase inhibitors in the treatment of colorectal cancer.BMC cancer · 2025Article
- The paradigm shift: re-evaluating preclinical animal models for colorectal cancer in the precision medicine era.Frontiers in immunology · 2025Review
- Autophagy inhibition improves sensitivity to the multi-kinase inhibitor regorafenib in preclinical mouse colon tumoroids.Frontiers in cell and developmental biology · 2025Article
- Exploring NUP62's role in cancer progression, tumor immunity, and treatment response: insights from multi-omics analysis.Frontiers in immunology · 2025Article
- Lipid metabolic reprogramming in colorectal cancer: mechanisms and therapeutic strategies.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
Immune checkpoint inhibitors (ICIs) have limited efficacy in microsatellite stable (MSS) metastatic colorectal cancer (mCRC), and combination therapy needs to be further explored. In this single-arm, open-label, phase II trial (NCT04745130), we evaluate the efficacy and safety of the combination therapy of antiangiogenesis (regorafenib) and ICI (sintilimab) in patients with MSS mCRC. The primary endpoint is overall survival (OS). Secondary endpoints include progression free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety. The median OS and PFS are 14.1 months (95% CI: 10.5-17.7) and 4.1 months (95% CI: 3.4-4.8), respectively. The ORR is 21.4%, DCR is 63.1%, and DoR is 13.0 months (95% CI: 2.5-23.5). Patients with RAS/RAF wild-type exhibit significantly longer median OS (23.3 months, 95% CI: 10.0-36.6) compared to those with mutations (12.1 months, 95% CI: 8.4-15.8). The combination therapy is well tolerated and has limited toxicity. Biomarker analysis, including transcriptome sequencing and multiplex immunohistochemistry staining are performed. The efficacy of this combination treatment is tied to specific gene expressions governing tumor metabolism. Moreover, the effectiveness of immunotherapy depends on the abundance of immune cells, as well as the distance between immune cells and tumor cells.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.