A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC)
The antitumor activity of chitooligosaccharides has been suggested. This phase 2 trial evaluated the efficacy and safety of T-ChOS™, in addition to adjuvant chemotherapy, in patients after resection of pancreatic ductal adenocarcinoma (PDAC). In this single-center, randomized, double-blind, placebo-...
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2022-02-01
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| Online Access: | https://www.mdpi.com/1999-4923/14/3/509 |
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| author | Susann Theile Julia Sidenius Johansen Dorte Lisbet Nielsen Benny Vittrup Jensen Carsten Palnæs Hansen Jane Preuss Hasselby Sverrir Vídalín Eiríksson Inna Markovna Chen |
| author_facet | Susann Theile Julia Sidenius Johansen Dorte Lisbet Nielsen Benny Vittrup Jensen Carsten Palnæs Hansen Jane Preuss Hasselby Sverrir Vídalín Eiríksson Inna Markovna Chen |
| author_sort | Susann Theile |
| collection | DOAJ |
| description | The antitumor activity of chitooligosaccharides has been suggested. This phase 2 trial evaluated the efficacy and safety of T-ChOS™, in addition to adjuvant chemotherapy, in patients after resection of pancreatic ductal adenocarcinoma (PDAC). In this single-center, randomized, double-blind, placebo-controlled trial using patients ≥18 years of age after complete macroscopic resection for PDAC, patients were randomly assigned (1:1) to either a continuous oral T-ChOS group or a placebo group, in combination with gemcitabine (GEM) and oral capecitabine (CAP), for a maximum of six cycles. The primary endpoint was disease-free survival (DFS). Recruitment was stopped prematurely in July 2018, with 21 of planned 180 patients included, due to poor accrual and because modified FOLFIRINOX replaced GEM/CAP for the target population. Nine patients received T-ChOS and twelve received the placebo. The median DFS was 10.8 months (95% CI 5.9–15.7) for the T-ChOS arm and 8.4 months (95% CI 0–21.5) in the placebo arm. Overall, seven patients (78%) in the T-ChOS arm and eight patients (67%) in the placebo arm experienced at least one grade 3–4 treatment-related adverse event, most frequently neutropenia. Altogether, the addition of T-ChOS to chemotherapy in patients after resection of PDAC seems safe. However, the clinical benefit cannot be assessed due to the premature cessation of the trial. |
| first_indexed | 2024-03-09T12:59:46Z |
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| id | doaj.art-5a0346c68163424ea72e48cb40bd3697 |
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| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T12:59:46Z |
| publishDate | 2022-02-01 |
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| series | Pharmaceutics |
| spelling | doaj.art-5a0346c68163424ea72e48cb40bd36972023-11-30T21:55:54ZengMDPI AGPharmaceutics1999-49232022-02-0114350910.3390/pharmaceutics14030509A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC)Susann Theile0Julia Sidenius Johansen1Dorte Lisbet Nielsen2Benny Vittrup Jensen3Carsten Palnæs Hansen4Jane Preuss Hasselby5Sverrir Vídalín Eiríksson6Inna Markovna Chen7Department of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, 2730 Herlev, DenmarkDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, 2730 Herlev, DenmarkDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, 2730 Herlev, DenmarkDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, 2730 Herlev, DenmarkDepartment of Surgery, Rigshospitalet, Copenhagen University Hospital, 2100 Copenhagen, DenmarkDepartment of Pathology, Rigshospitalet, Copenhagen University Hospital, 2100 Copenhagen, DenmarkGenís hf., 580 Siglufjörður, IcelandDepartment of Oncology, Herlev and Gentofte Hospital, Copenhagen University Hospital, 2730 Herlev, DenmarkThe antitumor activity of chitooligosaccharides has been suggested. This phase 2 trial evaluated the efficacy and safety of T-ChOS™, in addition to adjuvant chemotherapy, in patients after resection of pancreatic ductal adenocarcinoma (PDAC). In this single-center, randomized, double-blind, placebo-controlled trial using patients ≥18 years of age after complete macroscopic resection for PDAC, patients were randomly assigned (1:1) to either a continuous oral T-ChOS group or a placebo group, in combination with gemcitabine (GEM) and oral capecitabine (CAP), for a maximum of six cycles. The primary endpoint was disease-free survival (DFS). Recruitment was stopped prematurely in July 2018, with 21 of planned 180 patients included, due to poor accrual and because modified FOLFIRINOX replaced GEM/CAP for the target population. Nine patients received T-ChOS and twelve received the placebo. The median DFS was 10.8 months (95% CI 5.9–15.7) for the T-ChOS arm and 8.4 months (95% CI 0–21.5) in the placebo arm. Overall, seven patients (78%) in the T-ChOS arm and eight patients (67%) in the placebo arm experienced at least one grade 3–4 treatment-related adverse event, most frequently neutropenia. Altogether, the addition of T-ChOS to chemotherapy in patients after resection of PDAC seems safe. However, the clinical benefit cannot be assessed due to the premature cessation of the trial.https://www.mdpi.com/1999-4923/14/3/509adjuvant chemotherapychitinase 3-like 1 proteinchitooligosaccharidepancreatic cancerYKL-40 |
| spellingShingle | Susann Theile Julia Sidenius Johansen Dorte Lisbet Nielsen Benny Vittrup Jensen Carsten Palnæs Hansen Jane Preuss Hasselby Sverrir Vídalín Eiríksson Inna Markovna Chen A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC) Pharmaceutics adjuvant chemotherapy chitinase 3-like 1 protein chitooligosaccharide pancreatic cancer YKL-40 |
| title | A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC) |
| title_full | A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC) |
| title_fullStr | A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC) |
| title_full_unstemmed | A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC) |
| title_short | A Randomized Placebo-Controlled Phase 2 Study of Gemcitabine and Capecitabine with or without T-ChOS as Adjuvant Therapy in Patients with Resected Pancreatic Cancer (CHIPAC) |
| title_sort | randomized placebo controlled phase 2 study of gemcitabine and capecitabine with or without t chos as adjuvant therapy in patients with resected pancreatic cancer chipac |
| topic | adjuvant chemotherapy chitinase 3-like 1 protein chitooligosaccharide pancreatic cancer YKL-40 |
| url | https://www.mdpi.com/1999-4923/14/3/509 |
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