Abscopal Effect for Metastatic Colorectal Cancer

Status Withdrawn

Clinical Trial Summary

Patients with colorectal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study. 1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer patients. 2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer patients; 3. To explore the role of PET/CT scanning to assess tumor response/abscopal effect. This study will help find out what abscopal effects (good or bad) the combination of radiotherapy and thymalfasin has on metastatic esophageal cancer.

Clinical Trial Description

1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer patients. 2. To induce the efficacy (effectiveness) of a new combination of therapy, chemoradiotherapy and thymalfasin for heavily pretreated, metastatic esophageal cancer patients 3. To explore the role of PET/CT scanning to assess tumor responses/abscopal effect. Eligible are patients with metastatic colorectal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least three separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded both at CT and PET/CT scanning. Radiation is given during combined therapy to one of the lesions, 35Gy in 10 fractions over a two week interval, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days each week. At day 22 radiation is re-started and the same radiation dose is delivered to a second metastatic site, again with thymalfasin. Abscopal response is evaluated by assessing clinical and PET/CT response in the non-irradiated measurable metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no abscopal responses, the trial will be terminated. If there are one or more abscopal responses in Stage One, the trial will proceed to enroll an additional 19 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02535988
Study type	Interventional
Source	Zhejiang Provincial People's Hospital
Contact
Status	Withdrawn
Phase	Phase 2
Start date	September 2015
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Completed	`NCT00098787` - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer	Phase 2
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT05425940` - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer	Phase 3
Suspended	`NCT04595604` - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.	N/A
Completed	`NCT03414125` - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening	N/A
Completed	`NCT02963831` - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies	Phase 1/Phase 2
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Terminated	`NCT01847599` - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib	N/A
Recruiting	`NCT03874026` - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients	Phase 2
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Completed	`NCT03181334` - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation	N/A
Completed	`NCT03167125` - Participatory Research to Advance Colon Cancer Prevention	N/A
Recruiting	`NCT04258137` - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study	N/A
Not yet recruiting	`NCT05775146` - SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases	Phase 2
Recruiting	`NCT05568420` - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting	`NCT02972541` - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer	N/A
Completed	`NCT02876224` - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors	Phase 1
Completed	`NCT01943500` - Collection of Blood Specimens for Circulating Tumor Cell Analysis	N/A