Neoadjuvant Pembrolizumab with a Watch-and-wait Strategy for Patients with Mismatch Repair-deficient or Microsatellite Instability-high (dMMR/MSI-H) Localized Colon Cancer: a Randomized GERCOR G-109 PRODIGE 84 PREMICES Phase II Trial

The goal of this investigational study is to evaluate neoadjuvant pembrolizumab with a watch-and-wait approach for localized dMMR/MSI-H CRC patients. The PREMICES trial is based on the hypothesis that non-operative management is efficient for dMMR/MSI-H localized CRC patients treated with neoadjuvant pembrolizumab.
Eligible patients will be randomized to receive pembrolizumab with a watch-and-wait approach (experimental arm) or standard strategy (surgical resection ±adjuvant chemotherapy; control arm) in a 1:1 ratio.

开始日期2024-12-01

申办/合作机构

Groupe Coopérateur Multidisciplinaire en Oncologie

[+1]

NCT06580574 / Recruiting临床2期IIT

Sintilimab With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability

This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability

开始日期2024-08-13

申办/合作机构

北京大学

NCT05890742 / Recruiting临床3期

A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

开始日期2023-05-25

申办/合作机构

信达生物制药（苏州）有限公司

100 项与 MSI-H 结肠癌相关的临床结果

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100 项与 MSI-H 结肠癌相关的转化医学

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0 项与 MSI-H 结肠癌相关的专利（医药）

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项与 MSI-H 结肠癌相关的文献（医药）

2024-07-01·Targeted Oncology

Correction to: Efficacy and Safety of Neoadjuvant Subcutaneous Envafolimab in dMMR/MSI-H Locally Advanced Colon Cancer

作者: Lu, Zhenhai ; Wang, Hao ; Hu, Jinlong ; Zhang, Weili ; Feng, Cheng ; Zhang, Xuan ; Li, Yunfeng ; Pan, Zhizhong ; Hu, Ruixi ; Du, Jie ; Jin-Si-Han, E-Er-Man-Bie-Ke ; Zeng, Ziyang ; Lian, Shaopu ; Li, Yuan

2024-07-01·Targeted Oncology

Efficacy and Safety of Neoadjuvant Subcutaneous Envafolimab in dMMR/MSI-H Locally Advanced Colon Cancer

Article

作者: Lu, Zhenhai ; Wang, Hao ; Hu, Jinlong ; Feng, Cheng ; Zhang, Xuan ; Zhang, Weili ; Li, Yunfeng ; Pan, Zhizhong ; Hu, Ruixi ; Du, Jie ; Jin-Si-Han, E-Er-Man-Bie-Ke ; Zeng, Ziyang ; Lian, Shaopu ; Li, Yuan

BACKGROUNDNeoadjuvant immunotherapy with programmed death-ligand 1 blockade for colon cancer, especially for mismatch repair-deficient (dMMR)/high microsatellite instability (MSI-H) colon cancer, has gained considerable attention recently.OBJECTIVEThis study aimed to assess the safety and efficacy of neoadjuvant subcutaneous envafolimab in patients with dMMR/MSI-H locally advanced colon cancer.METHODSPatients with dMMR/MSI-H locally advanced colon cancer treated with envafolimab at Sun Yat-sen University Cancer Center and Yunnan Cancer Hospital from October 2021 to July 2023 were retrospectively reviewed and analyzed. The primary endpoint was the pathological complete response (CR) rate, and secondary endpoints were treatment-related adverse events and complete clinical response rate.RESULTSOverall, 15 patients were analyzed. After neoadjuvant immunotherapy with envafolimab, six patients achieved a CR, with five partial responses, and four stable disease. Three patients achieving a complete clinical response chose to accept a "watch and wait" strategy, and surgery was performed in 12 patients. Postoperative pathology results revealed seven patients achieved pathological CRs, and five patients achieved tumor regression grade 2, with 66.7% of the total CR rate. The most common treatment-related adverse events were pruritus and rash (40%), with no severe cases. No recurrences occurred over a 7.9-month follow-up.CONCLUSIONSEnvafolimab yielded promising surgical outcomes and safety in dMMR/MSI-H locally advanced colon cancer, representing a promising treatment modality for this population.

2024-02-01·Clinical Journal of Gastroenterology

Complete pathologic response after laparoscopic hepatectomy following treatment with nivolumab and ipilimumab for anticancer drug-resistant MSI-high colon cancer liver metastasis consisting of poorly differentiated adenocarcinoma with squamous differentiation: A case report

Article

作者: Ohuchi, Mayuko ; Sawayama, Hiroshi ; Komohara, Yoshihiro ; Yoshida, Naoya ; Ogawa, Katsuhiro ; Baba, Hideo ; Kato, Moeko ; Hisano, Yuki ; Nakamura, Hiro ; Miyamoto, Yuji

A 56-year-old man referred to our hospital for cecum cancer. Enhanced computed tomography (CT) found swollen reginal lymph nodes and liver metastasis. Magnetic Resonance Imaging (MRI) revealed a solitary lesion on liver (S2). We performed a laparoscopic ileocolic resection and liver partial resection. Tumor pathology showed that these tumors were moderate-differentiated adenocarcinoma (pT3N2bM1 Stage IVA). Genetic examination revealed MSI-high, KRAS wild type, and BRAF wild type. After surgery, two liver metastases were found in S4 and S7 as new lesion in EOB-MRI. We started chemotherapy with the FOLFOFIRI plus bevacizumab regimen, but two liver metastases were enlarged after six cycles of chemotherapy. As a second-line treatment, nivolumab and ipilimumab combination therapy was started. After three cycles of these therapy, both of these tumors shrinkage were observed. We performed laparoscopic liver resection. In specimens, there were no malignant cells. Pathological study revealed that in the initial surgery specimen, PD-L1 protein was detected in both primary and metastatic lesions, and HLA-DR, CK5/6 in liver. No recurrence was observed at 6 months after the surgery. In conclusion, we reported the case of anticancer drug-resistant MSI-high colon cancer liver metastasis was resected after treatment with immune-checkpoint inhibitors and a pathological complete response was found.