Editor’s Note: At the 2024 European Society for Medical Oncology (ESMO) Asia Annual Meeting, nine TiP abstracts focused on colorectal cancer from China were presented. Previously, we summarized four of them. In this article, we spotlight the remaining five studies led by Dr. Jun Huang from the Sixth Affiliated Hospital, Sun Yat-sen University, offering readers an overview of these significant contributions.Abstract ID: 117TiP
Title: Safety and Efficacy of Reduced-Port Laparoscopic Surgery for Colon and Upper Rectal Cancer: A Multicenter, Prospective, Randomized Phase III Study
Background
Radical resection remains the cornerstone of non-metastatic colorectal cancer (CRC) treatment. Traditional laparoscopic surgery often involves an assistant, whose varying skill levels and experience can result in unintentional damage and prolong surgical procedures. Reduced-port laparoscopic surgery, which simplifies the setup to two operation ports for the surgeon and one observation port for the assistant, allows the surgeon to independently perform the operation. This method reduces reliance on assistants, potentially shortening surgical time and minimizing risks. Additionally, with fewer incisions, this approach may result in reduced postoperative pain, faster recovery, and lower medical costs.
Study Design
This multicenter, open-label, randomized, parallel-design Phase III trial is conducted in China. Patients are randomized 1:1 through a computerized management system to either the reduced-port laparoscopic surgery group (three ports) or the traditional laparoscopic surgery group (five ports). This is the first prospective randomized controlled trial evaluating the safety and efficacy of reduced-port laparoscopic surgery for resectable CRC. The key endpoints include perioperative complications, R0 resection rate, and 3-year disease-free survival (DFS) and overall survival (OS).
The inclusion criteria for the study are patients with clinical staging of CRC as Stage I–III (cTxNxM0), histologically confirmed colorectal adenocarcinoma, and the ability to provide informed consent. The exclusion criteria include a history of other malignancies, complications requiring emergency surgery, unresectable lymph node metastases, and high ASA or ECOG scores.
The study aims to enroll 500 patients. As of May 5, 2024, 128 patients have been recruited.
The clinical trial is registered under ID: NCT05953662.
Abstract ID: 121TiP
Title: Comparison of Anorectal Function after Parks and Bacon Anastomosis in Low Rectal Cancer: A Multicenter, Prospective, Randomized Controlled Trial
Background
Low rectal cancer (LRC), defined as tumors located ≤3 cm from the dentate line, poses significant challenges in balancing effective oncologic treatment with preserving anorectal function. While previous studies suggest comparable disease-free survival (DFS) and overall survival (OS) between the Parks and Bacon procedures, no large-scale randomized controlled trials (RCTs) have directly compared their impacts on anorectal function, quality of life, complications, and survival.
Study Design
This multicenter, prospective, randomized controlled trial conducted in China aims to address this gap. Eligible LRC patients are randomized 1:1 via a computerized system into either the Parks or Bacon procedure groups. The Parks procedure involves coloanal anastomosis, while the Bacon procedure utilizes a pull-through coloanal anastomosis.
Postoperative anorectal function is assessed using anorectal manometry and the low anterior resection syndrome (LARS) score at 3, 6, and 12 months. Additional evaluations include quality-of-life scores and the incidence of anastomotic complications.
The inclusion criteria require MRI-confirmed LRC with tumors ≤3 cm from the dentate line, multidisciplinary consensus supporting sphincter-preserving surgery, and the patient’s ability to provide informed consent. The exclusion criteria include a history of other malignancies, urgent complications requiring immediate surgery, unresectable tumor extension, and high ASA or ECOG scores.
The study plans to enroll 265 patients. As of May 5, 2024, 8 patients have been recruited.
Abstract ID: 122TiP
Title: “Watch-and-Wait” Strategy for Patients with dMMR/MSI-H Distal Rectal Cancer Achieving Pathological Complete Response After PD-1 Inhibitor Therapy (BASKET)
Background
PD-1 inhibitors have shown remarkable efficacy in CRC patients with DNA mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H). In particular, neoadjuvant immunotherapy has demonstrated promising pathological complete response (pCR) rates in these patients. However, radical resection of distal rectal cancer (RC) often leads to functional impairments and psychological distress. For patients with early or locally advanced (Stage I–III) dMMR/MSI-H distal RC, the feasibility and safety of a “watch-and-wait” strategy following clinical complete response (cCR) to PD-1 inhibitors remain unclear.
Study Design
The BASKET study is an open-label, multicenter, prospective Phase II trial conducted in China. Eligible patients with dMMR/MSI-H distal RC receive neoadjuvant immunotherapy with intravenous 200 mg sintilimab (PD-1 inhibitor) on Day 1 of a 3-week cycle for six cycles. Patients achieving cCR, confirmed by imaging and biopsy, transition to a “watch-and-wait” strategy.
This is the first prospective study evaluating the safety and efficacy of the “watch-and-wait” approach in these patients, aiming to provide guidance for individualized treatment strategies to preserve organ function and improve quality of life. Key inclusion criteria include biopsy-confirmed dMMR/MSI-H tumors by IHC or next-generation sequencing, tumors located below the peritoneal reflection on MRI, and clinical staging of TxNxM0. Exclusion criteria include Stage IV distal RC, multiple CRCs, active autoimmune diseases, or prolonged corticosteroid use.
The study aims to enroll 47 patients. As of May 1, 2024, 10 patients have been recruited.
Clinical trial ID: NCT04643041
Abstract ID: 123TiP
Title: A Dynamic Multi-Omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer
Background
Neoadjuvant therapy significantly improves pCR rates and outcomes in CRC patients. Factors such as reduced carcinoembryonic antigen (CEA) levels, tumor shrinkage, decreased circulating tumor DNA (ctDNA) levels, lower neutrophil-to-lymphocyte ratio (NLR), and enhanced MRI signals may predict pCR. Accurate pCR prediction could support the use of “watch-and-wait” strategies for locally advanced rectal cancer (LACR) patients.
Study Design
This multicenter, prospective, observational Phase II study aims to develop and validate a dynamic multi-omics integration model to predict pCR in LACR patients (T3–4NxM0) receiving neoadjuvant therapy. It is the first prospective study assessing this model’s accuracy and advantages over traditional imaging, pathology, or molecular biomarker-based prediction models.
Eligible patients will undergo pre-treatment, interim, and preoperative MRI scans, H&E staining of tumor biopsy samples, and assessments of CEA, NLR, and ctDNA levels. Changes in these features, along with results from multi-stage biopsies, will be integrated into the prediction model. Outcomes will be validated by pathological tumor responses in resected specimens.
Patients with histologically confirmed rectal adenocarcinoma, clinical staging of T3–4NxM0, and no prior chemoradiotherapy or colorectal surgery are eligible. Exclusion criteria include complications requiring long-term immunosuppressants, a history of substance abuse, and evidence of pelvic or distant metastases within five years.
The study plans to enroll 106 patients.
Clinical trial ID: NCT06364371
Abstract ID: 124TiP
Title: Safety and Efficacy of PD-1 Inhibitors with or without mFOLFOX6 Neoadjuvant Therapy in Locally Advanced dMMR/MSI-H Synchronous Multiple Primary Colorectal Cancer Patients
Background
Synchronous multiple primary colorectal cancer (sMPCC) is rare but increasingly reported. Prior studies suggest a higher prevalence of dMMR/MSI-H in sMPCC patients compared to single primary CRC (SPCRC) patients. While PD-1 inhibitors show significant efficacy in dMMR/MSI-H SPCRC, their role in neoadjuvant treatment for locally advanced dMMR/MSI-H sMPCC remains uncertain.
Study Design
This open-label, multicenter, prospective Phase II trial in China evaluates the safety and efficacy of neoadjuvant immunotherapy in patients with locally advanced dMMR/MSI-H sMPCC.
Patients are categorized into three subtypes:
- Mixed dMMR/MSI-H and pMMR/MSS lesions.
- All lesions are dMMR/MSI-H.
- All lesions are pMMR/MSS.
The study includes patients from subtypes 1 and 2. Mixed MMR patients receive six cycles of bi-weekly neoadjuvant therapy with mFOLFOX6 and PD-1 inhibitors. Those with exclusively dMMR/MSI-H lesions receive PD-1 inhibitor monotherapy for six cycles.
This is the first prospective study assessing neoadjuvant immunotherapy for locally advanced dMMR/MSI-H sMPCC. Results are expected to guide personalized treatment strategies for sMPCC patients.
Inclusion criteria require histologically confirmed sMPCC with dMMR/MSI-H verified by IHC or next-generation sequencing and clinical staging of cT3–4NxM0. Exclusion criteria include Stage IV disease, long-term immunosuppressant exposure, and refusal to provide informed consent. The study aims to enroll 17 patients.
Clinical trial ID: NCT06002789
