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Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Regorafenib as Adjuvant Therapy for Colorectal Liver Metastasis Patients With a High Risk of Recurrent: a Single-arm, Phase II Study

ABSTRACT: Pts with histologically confirmed CRLM and whose CRS >2 were enrolled into this single-arm, phase II study. The critical enrollment criteria were that Subjects had completely resected Primary lesion and liver metastases and had no evidence of extrahepatic disease. After hepatectomy， HAIC (FOLFOX: oxaliplatin 85mg/m2, 5- fluorouracil 2500mg/m2, calcium folinate 400mg/m2) was given every 4-6 weeks for 2-4 cycles depending on pts’ health status, in combination with Sintilimab (200mg, iv, d1) and regorafenib (80mg, po, d1-21) every 3 weeks for up to 6 months. The primary endpoint was 1-year recurrence-free survival (RFS) and secondary endpoints included RFS, overall survival (OS), safety, and health-related quality of life.

DISEASE(S): Colorectal Liver Metastasis,Neoplasm Metastasis,Liver Neoplasms

PROVIDER: 10268 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase II Clinical and Immune Correlate Study of Adjuvant Nivolumab plus Ipilimumab for High-Risk Resected Melanoma

Project description:Background: Adjuvant therapy for high-risk resected melanoma with PD-1 blockade results in median relapse-free survival (RFS) of 5 years. The addition of low dose ipilimumab (IPI) to a regimen of nivolumab (NIVO) in Checkmate-915, did not result in increased RFS. A pilot phase II adjuvant study of either standard or low dose IPI with NIVO was conducted at two centers to evaluate RFS with correlative studies. Methods: Patients (pts) with resected stages IIIB/IIIC/IV melanoma received either IPI 3mg/kg and NIVO 1mg/kg (cohort 4) or IPI 1mg/kg and NIVO 3mg/kg (cohorts 5 and 6) induction therapy every three weeks for 12 weeks, followed by maintenance NIVO. Peripheral blood samples at baseline and on-treatment were assessed by flow cytometry for potential biomarkers. Peripheral CD8+ T-cells were assessed by RNA-Seq. Results: High rates of grade 3-4 adverse events precluded completion of induction therapy in 50%, 35% and 7% of patients in cohorts 4, 5 and 6 respectively. At a median of 63.9 months of follow up, 16/56 pts (29%) relapsed. For all patients, at five-years, RFS was 71% (95% CI: 60, 84), and overall survival was 94% (95% CI: 88, 100). Expansion of CD3+CD4+CD38+CD127-GARP- T-cells, an on-treatment increase in CD39 expression in CD8+ T-cells, and T-cell expression of phosphorylated STAT2 and STAT5 were associated with relapse. Conclusions: Adjuvant IPI/NIVO at the induction doses used resulted in excellent relapse-free survival, albeit with a high rate of grade 3-4 adverse events. Biomarker analyses highlight an association of ectoenzyme-expressing T-cells and STAT signaling pathways with relapse.

2022-12-02 | GSE219251 | GEO

A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer

Project description:Interventions: mFOLFOX6 5FU bolus: 400 mg/m2 d1 5FU infusion: 2400 mg/m2/46h d1 Oxaliplatin: 85mg/m2 d1 l-LV: 200mg/m2 d1 Q2w Primary outcome(s): Disease control rate after 12 weeks of treatment. Study Design: Single arm Non-randomized

| 2620327 | ecrin-mdr-crc

An Exploratory Study for the Efficacy and Safety of Cetuximab in Combination with Irinotecan Re-challenge Versus Regorafenib in the Third-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer

Project description:Interventions: Experimental group:Cetuximab-targeted combination with irinotecan chemotherapy, the specific regimen is as follows: Cetuximab (trade name: Erbitux) once every two weeks, 500 mg/m2, d1; Irinotecan 180 mg/m2 ivgtt 90 min d1 q2w;Control group:Regorafenib oral treatment, the specific regimen is as follows: regorafenib 120 mg d1-21 q4w Primary outcome(s): Progression-free survival Study Design: Parallel

| 2687922 | ecrin-mdr-crc

FOLFIRI plus cetuximab as first-line therapy followed by cetuximab maintenance therapy in patients with RAS and BRAF wild-type unresectable metastatic colorectal cancer: a single institute study

Project description:Interventions: Experimental group:cetuximab 500 mg/m2 d1, combined with irinotecan 180 mg/m2 d1, intravenous drip 90 min d1, every 2 weeks as a cycle, record the disease control. In the maintenance phase1 group, if reach disease control (PR, CR, SD) after 6-12 cycles of treatment, according to the adverse effects of patients and per;Control group:Nil Primary outcome(s): Failure-free survival Study Design: Non randomized control

| 2687328 | ecrin-mdr-crc

A Phase II Study of Neoadjuvant Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Breast Cancer

Project description:This phase II study examined the pathological complete response (pCR) rate and safety of two gemcitabine-based combinations administered sequentially in breast cancer. We also examined gene expression profiles from tumor biopsies to identify biomarkers predictive of response. Methods: Indian women with large or locally advanced breast cancer received 4 cycles of gemcitabine 1200 mg/m2 plus doxorubicin 60 mg/m2 (Gem+Dox), then 4 cycles of gemcitabine 1000 mg/m2 plus cisplatin 70 mg/m2 (Gem+Cis), and surgery. To examine dynamic changes in molecular profiles after one dose of therapy, we used three alternate sequences during cycle 1 (Gem d1, 8; Dox d2; Gem d1, 8; Dox d1; or Gem d2, 8; Dox d1). Results: Of 65 women (median age 46) treated, 13 (24.5% of 53 patients with surgery) had a pCR and 22 (33.8%) had a complete clinical response. Patients who received Gem d1, 8 and Dox d2 in cycle 1 (20/65) reported more toxicities, with G3/4 neutropenic infection/febrile neutropenia (7/20) and vomiting (5/20) as the most common cycle 1 events. Four drug-related deaths occurred. 46/65 patients yielded successful pretreatment gene expression profiles. Ten-fold cross-validated supervised analyses identified gene expression patterns that predicted with >73% accuracy (1) clinical complete response after eight cycles, (2) overall clinical complete response, and (3) pCR. Conclusions: This neoadjuvant regimen showed strong activity. A subset of patients receiving Gem d1, 8 and Dox d2 experienced unacceptable toxicity, whereas patients on other sequences had more manageable safety profiles. The predictive gene expression patterns may provide a method for selecting patients most likely to benefit from gemcitabine-containing neoadjuvant therapy. Key words: breast cancer, chemotherapy, gemcitabine, , gene expression, microarrays, neoadjuvant therapy Keywords: Dose response

2008-01-12 | GSE8465 | GEO

A phase I/II study of Lonsurf combined with Oxaliplatin in metastatic colorectal cancer patients refractory to standard chemotherapy.

Project description:Interventions: Lonsurf/L-OHP therapy Lonsurf: 70mg/m2, d1-5, d15-19 (fixed dose) L-OHP: 50-85mg/m2, d1,d15 (dose escalation) every 4 weeks Primary outcome(s): [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part]Disease Control Rate (DCR) Study Design: Single arm Non-randomized

| 2631090 | ecrin-mdr-crc

A Randomized, Controlled, Multicenter Clinical Trial of Kangai Injection in Combination with Chemotherapy XELOX in Treatment of Colorectal Cancer

Project description:Interventions: Experiment group:Kangai injection 60ml ivgtt D1-14 Q21d, combined with chemotherapy: Eloxatin 130mg/m2 2h ivgtt d1, Xeloda 1000mg/m2 bid po d1-14 Q21d;Control group:Chemotherapy: Eloxatin 130mg/m2 2h ivgtt d1, Xeloda 1000mg/m2 bid po d1-14 Q21d Primary outcome(s): Adverse Reactions Study Design: Randomized parallel controlled trial

| 2674808 | ecrin-mdr-crc

Integrative transcriptomic characterization of matched primary and hepatic metastases of pancreatic ductal adenocarcinoma

Project description:Background: Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers due to its high metastasis rate in liver. However, little is known about the molecular features of hepatic metastases due to difficulty in obtaining fresh tissues and low tumor cellularity. Methods and Results: We conducted RNA sequencing for synchronous surgically resected PTs and the paired HMs from 14 hepatic oligometastatic PDACs and experimentally validated our findings in specimens from 35 of such cases. The comprehensive analysis of gene expressions showed largely similarity between PTs and HMs. However, hepatic metastases also showed unique characteristics, such as stronger abilities of proliferation, downregulation of EMT activity and metabolic rewiring. More interesting, altered tumor microenvironments were observed in hepatic metastases, especially higher proportion of tumor infiltrating M2 macrophage and upregulation of complement cascade. Further experiments demonstrate that expression of C1q increased continuously from normal to PTs to HMs, C1q was mainly produced from M2 macrophage, and C1q promoted migration and invasion of PDAC cells. Conclusion: Taken together, we found potential factors that contribute to different stages of PDAC metastasis. Our study broadens the understandings of molecular mechanisms driving PDAC metastasis.

2020-06-02 | GSE151580 | GEO

A non-inferiority study of apatinib versus bevacizumab combined with XELOX regimen in the treatment of metastatic colorectal cancer

Project description:Interventions: Experimental group:Apatinib 250mg po, qd, continuous taken; XELOX: Oxaliplatin 135 mg/m2 Ivgtt d1, Capecitabine 1000mg/m2 d1-14, q3w;Control group:Bevacizumab 7.5mg/kg, q3w; XELOX: Oxaliplatin 135 mg/m2 Ivgtt d1, Capecitabine 1000mg/m2 d1-14, q3w Primary outcome(s): Progress-free survival (PFS) Study Design: Non randomized control

| 2687981 | ecrin-mdr-crc

Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer

Project description:Interventions: Irinotecan was infused 150 mg/m2 for pts with *1/*1 genotype and 70 mg/m2 for *1/*28. Irinotecan was infused 150 mg/m2 for pts with *1/*1 genotype and 70 mg/m2 for *1/*28. Primary outcome(s): Response rate Study Design: expanded access Non-randomized

| 2620453 | ecrin-mdr-crc

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