Editor’s Note: The European Society for Medical Oncology (ESMO) Asia Annual Meeting was held in Singapore, focusing on the latest oncology advancements in Asia. This conference provided a platform for participants to share and discuss novel research findings, clinical trials, and treatment strategies.Among the featured presentations, Trial in Progress (TiP) abstracts offered insights into promising ongoing studies. These abstracts, identified with the code “xxTiP,” represent research still in progress or in the early stages.These studies reveal potential trends in the field and inspire new directions for clinical research. This article summarizes four TiP abstracts from the Chinese colorectal cancer field. The remaining five, led by Dr. Jun Huang from the Sixth Affiliated Hospital, Sun Yat-sen University, will be discussed in a follow-up article.Abstract ID: 119TiP
Title: A Randomized, Controlled, Multicenter Phase III Study of IBI310 (Anti-CTLA-4 Antibody) Plus Sintilimab (Anti-PD-1 Antibody) as Neoadjuvant Therapy for Resectable MSI-H/dMMR Colon Cancer
Presenter: Professor Ruihua Xu, Sun Yat-sen University Cancer Center
Background
For colon cancer, particularly MSI-H/dMMR subtypes, traditional neoadjuvant chemotherapy has shown limited efficacy, making the development of effective neoadjuvant strategies critical. PD-1 inhibitors, with or without CTLA-4 inhibitors, have demonstrated encouraging results in metastatic MSI-H/dMMR colorectal cancer. However, no such combination has been approved as neoadjuvant therapy for localized tumors.
At the 2024 ASCO Annual Meeting, a randomized Phase Ib study (Abstract #3505) revealed that the combination of IBI310 and sintilimab significantly improved pathological complete response (pCR) rates compared to sintilimab monotherapy in MSI-H/dMMR colon cancer.
Study Design
The ongoing Neoshot Phase III study in China aims to evaluate the efficacy of IBI310 combined with sintilimab as neoadjuvant therapy compared to surgery alone in Stage IIb–III MSI-H/dMMR colon cancer. A total of 350 patients will be enrolled and randomized equally into the experimental and control groups. Stratification factors include baseline imaging risk assessment (high risk: T4 or N2; low risk: T1–3 and N1) and tumor location (left-side vs. right-side).
Patients eligible for the study must be at least 18 years old, with treatment-naïve colon adenocarcinoma staged as IIb–III (cT4 or cN+ based on the AJCC 8th Edition). Tumors must be resectable with R0 margins, and patients must have confirmed MSI-H or dMMR status and an ECOG Performance Status of 0 or 1.
In the experimental group, patients receive neoadjuvant therapy consisting of IBI310 (1 mg/kg) combined with sintilimab (200 mg) in the first cycle, followed by sintilimab (200 mg) alone in the second cycle. Radical surgery is performed within 36–56 days after the first dose. The control group undergoes radical surgery without neoadjuvant therapy.
Postoperative adjuvant chemotherapy with oxaliplatin plus capecitabine is determined based on pathological evaluation and clinical guidelines. The study’s primary endpoints include the pCR rate in the experimental group and event-free survival. Secondary endpoints include the R0 resection rate, overall survival, safety, pharmacokinetics, and immunogenicity.
Abstract ID: 118TiP
Title: Neoadjuvant CAPOX Combined with SCT510 (Bevacizumab Biosimilar) and Finotonlimab for High-Risk Resectable Colorectal Cancer Liver Metastases (CRLM): A Multicenter Phase II Study Presenter: Professor Wensheng Qiu, Qingdao University Affiliated Hospital
Background
Surgical resection remains the primary curative approach for colorectal cancer liver metastases (CRLM). Preoperative treatments, including chemotherapy or combinations with immunotherapy, have improved the eligibility of patients for curative surgery. However, microsatellite-stable (MSS) tumors generally exhibit poor responses to immunotherapy. Combining immunotherapy with anti-angiogenesis strategies could potentially enhance the response rate in MSS CRLM.
SCT510, a recombinant anti-VEGF antibody, has demonstrated comparable safety, pharmacokinetics, and immunogenicity to bevacizumab. Finotonlimab, a novel anti-PD-1 antibody, has shown efficacy in treating solid tumors. The prospective Phase II NEO CPLUS study was initiated to evaluate the efficacy and safety of CAPOX combined with SCT510 and finotonlimab as neoadjuvant therapy for high-risk resectable CRLM.
Study Design
The NEO CPLUS trial is a multicenter, single-arm, investigator-initiated Phase II study (ChiCTR2400085958) aiming to enroll approximately 100 patients. Eligible participants are aged 18–75, with histologically confirmed, high-risk resectable CRLM (clinical risk score ≥3). Resectability is defined as technically feasible complete resection, with metastases confined to the liver and a maximum of six lesions. Patients must have an ECOG Performance Status of 0–2, MSS/pMMR disease, and adequate organ function.
Participants receive three cycles of CAPOX (130 mg/m² oxaliplatin on Day 1 and 1000 mg/m² capecitabine twice daily on Days 1–14), SCT510 (7.5 mg/kg on Day 1), and finotonlimab (200 mg on Day 1), followed by one cycle of CAPOX combined with finotonlimab. Each cycle lasts 21 days.
Following 2–4 treatment cycles, patients with radiological responses or stable disease, as assessed by RECIST 1.1 criteria, undergo surgery within 4–6 weeks. Post-surgery, up to four cycles of adjuvant CAPOX combined with SCT510 are allowed.
The study’s primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include 1-year progression-free survival, major pathological response, R0 resection rate, R1 resection rate, and safety outcomes.
Abstract ID: 120TiP
Title: Neoadjuvant Short-Course Radiotherapy Combined with Chemotherapy and Cadonilimab for Locally Advanced Rectal Cancer: A Prospective, Single-Arm Phase II Trial Presenter: Jiawei Rao, Guangzhou, China
Background
The standard treatment for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (CRT), which significantly reduces the risk of local recurrence. However, distant metastases remain a challenge. Recent studies suggest that short-course radiotherapy (SCRT) combined with PD-L1 inhibitors may enhance tumor response and prognosis. Cadonilimab (AK104), a novel bispecific antibody targeting both PD-1 and CTLA-4, aims to augment antitumor activity while minimizing toxicity. Combining cadonilimab with SCRT and chemotherapy could provide greater clinical benefits and improve outcomes for LARC patients.
Study Design
This Phase II, single-center, single-arm trial evaluates the efficacy and safety of SCRT combined with CAPEOX (capecitabine and oxaliplatin) and cadonilimab as neoadjuvant therapy for LARC. Patients must have histologically confirmed rectal adenocarcinoma staged as T3–T4/N+M0, be aged 18–70, have an ECOG PS score of 0–1, and exhibit normal organ function.
Treatment involves one cycle of CAPEOX combined with AK104 (10 mg/kg intravenously on Day 1 every three weeks), followed by SCRT (25 Gy, 5 Gy/day during Days 8–12) and two additional cycles of CAPEOX with AK104. Total mesorectal excision (TME) is performed two weeks after the final neoadjuvant therapy cycle. Postoperative treatment includes five cycles of adjuvant CAPEOX chemotherapy.
The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response rate, R0 resection rate, 1- and 3-year disease-free survival (DFS) rates, 1- and 3-year overall survival (OS) rates, and safety.
Using Simon’s two-stage design, the first stage enrolls 15 patients; if six or more achieve pCR, the second stage will recruit 22 additional patients. Tumor and blood samples will be collected for further research. As of June 2024, 10 patients have been enrolled.
Clinical Trial ID: ChiCTR2300075658
Abstract ID: 125TiP
Title: Prophylactic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Locally Advanced Colorectal Cancer: A Single-Center, Open-Label, Randomized Controlled Trial Presenter: Shiyu Xu, Guangzhou, China
Background
Colorectal cancer (CRC) ranks as the third most common malignancy worldwide. Peritoneal recurrence is relatively frequent in CRC, with progression to peritoneal carcinomatosis (PC) often leading to poor prognosis. Reducing peritoneal recurrence and improving survival outcomes remain significant challenges. Previous studies indicate that adjuvant HIPEC may reduce peritoneal micro-metastases in ovarian, appendiceal, and gastric cancers, offering a potential strategy for CRC treatment.
This open-label, single-center, randomized prospective trial assesses whether prophylactic HIPEC reduces peritoneal recurrence and improves survival in CRC patients with high-risk factors for peritoneal metastases (cT3–T4a stage). Patients aged 18–75 with pathologically confirmed colorectal adenocarcinoma, no distant metastases, and good tolerance for postoperative HIPEC are eligible.
Participants will be randomized 1:1 into the experimental or control groups. In the experimental group, patients undergo standard radical surgery with lymph node dissection and intraoperative placement of four HIPEC catheters. HIPEC treatment is administered on the day of surgery or the following day using raltitrexed (4 mg, 43°C saline, 3000 ml, 60 minutes). A second HIPEC session follows within a week using oxaliplatin (130 mg/m², 43°C 5% glucose solution, 3000 ml). Both groups receive systemic chemotherapy with CapeOX/capecitabine/mFOLFOX6 approximately one-month post-surgery.
The primary endpoint is the 3-year peritoneal recurrence rate. Secondary endpoints include 3-year DFS, 3- and 5-year OS, postoperative quality of life, perioperative complications, and HIPEC toxicity at 1 and 6 months postoperatively.
This study seeks to determine whether prophylactic HIPEC can prevent peritoneal recurrence and improve outcomes in high-risk CRC patients, potentially establishing a new standard of care.
