ArticleBMC cancer2022
Rationale and design of a prospective, multicenter, phase II clinical trial of safety and efficacy evaluation of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorectal excision for locally advanced rectal cancer (NCRT-PD1-LARC trial).
Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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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.
Rationale and Design of a Prospective, Multicenter Phase Ⅱ Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.
The Efficacy and Safety of Preoperative Neoadjuvant Chemoradiation Combined With PD-1 Inhibitor and PCSK9 Inhibitor in the Treatment of pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: a Multicenter Study, Prospective, Randomized Controlled Study
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- The efficacy and safety of neoadjuvant treatment with the PD-1 inhibitor for locally advanced colorectal cancer: a meta-analysis.Frontiers in oncology · 2024Pooled it
- Surufatinib plus tislelizumab as later-line therapy for metastatic colorectal cancer: a single-arm, phase II trial.BMC cancer · 2026Trial
- Diagnostic accuracy and pitfalls of MRI for restaging locally advanced rectal cancer in patients following anti-PD1 therapy plus neoadjuvant chemoradiotherapy: a multicenter study.Abdominal radiology (New York) · 2026Trial
- Efficacy and safety of PD-1 blockade plus long-course chemoradiotherapy in locally advanced rectal cancer (NECTAR): a multi-center phase 2 study.Signal transduction and targeted therapy · 2024Trial
- Clinical Features and Factors Contributing to Preoperative Misdiagnosis of Gastric Gastrointestinal Stromal Tumors: A Retrospective Analysis of 27 Cases.Gastroenterology research and practice · 2026Article
- Gut microbiota and neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a review of current evidence and emerging insights.Therapeutic advances in medical oncology · 2026Review
- Contemporary Surgical Management of Colorectal Cancer in Lynch Syndrome: Considering the Implications of Known Genotype.ANZ journal of surgery · 2025Review
- Article
- Clinical Effectiveness of Tislelizumab With Gemcitabine/Cisplatin Versus Gemcitabine/Cisplatin Alone as Adjuvant Therapy for High-Risk Muscle-Invasive Urothelial Carcinoma: A Real-World Study.Cancer medicine · 2025Article
- Comparison of currently common neoadjuvant therapy strategies for rectal cancer: a three-arm retrospective study.Frontiers in cellular and infection microbiology · 2025Article
- PD-L1 Expression in Paired Samples of Rectal Cancer.Cancers · 2024Article
- Inhibition of PCSK9: A Promising Enhancer for Anti-PD-1/PD-L1 Immunotherapy.Research (Washington, D.C.) · 2024Review
- Article
- Radiotherapy in the preoperative neoadjuvant treatment of locally advanced rectal cancer.Frontiers in oncology · 2023Review
- Total neoadjuvant treatment and PD-1/PD-L1 checkpoint inhibitor in locally advanced rectal cancer.Frontiers in immunology · 2023Review
- Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?Frontiers in immunology · 2023Review
- Radioimmunotherapy in colorectal cancer treatment: present and future.Frontiers in immunology · 2023Review
- Interim result of phase II, prospective, single-arm trial of long-course chemoradiotherapy combined with concurrent tislelizumab in locally advanced rectal cancer.Frontiers in oncology · 2023Article
- Pathological Complete Response Following Neoadjuvant Tislelizumab Monotherapy in Treatment-Naive Locally Advanced, MMR-Deficient/MSI-High Ascending Colon Cancer: A Case Report.Journal of clinical medicine · 2022Article
- Current progress and future perspectives of neoadjuvant anti-PD-1/PD-L1 therapy for colorectal cancer.Frontiers in immunology · 2022Review
Corrections and comments
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Authors and funding
17 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLong course radiotherapy plus neoadjuvant chemotherapy followed by resection (total mesorectal excision, TME) has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Tislelizumab, an anti-PD1 humanized IgG4 monoclonal antibody, has been demonstrated with clinical activity and is approved for treating recurrent/refractory classical Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma in China. However, the safety and efficacy of long course (neoadjuvant chemoradiotherapy, NCRT) plus tislelizumab followed by TME for LARC is still uncertain.
methodsThis NCRT-PD1-LARC trial will be a prospective, multicenter and phase II clinical trial designed to evaluate the safety and efficacy of LARC patients treated with long course NCRT plus tislelizumab followed by TME. This trial will consecutively enroll 50 stage II/III LARC patients (cT3N0M0 and cT1-3N1-2M0) with the tumor distal location ≤ 7 cm from anal verge at 7 centers in China. The enrolled patients will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by TME 6-8 weeks after the end of radiotherapy. The primary efficacy endpoint will be the pathological complete response (pCR) rate, which is defined as absence of viable tumor cells in the primary tumor and lymph nodes. DISCUSSION: To our knowledge, this trial is the first multicenter clinical trial in China to assess the safety and efficacy of NCRT plus anti-PD1 therapy followed by TME to treat patients with LARC. NCRT followed by TME was recognized as the most recommended treatment against LARC while could not be completely satisfied in clinic. This study expects to provide a solid basis and encouraging outcomes for this promising combination of radiotherapy, chemotherapy and immunotherapy in LARC.
trial registrationName of the registry: ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: NCT04911517. Date of registration: 23 May 2021. URL of trial registry record: https://www. CLINICALTRIALS: gov/ct2/show/NCT04911517?id=BFH-NCRTPD&draw=2&rank=1 .
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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.