Indexing hint: Animal study · 2020
Thymosin α1 protects from CTLA-4 intestinal immunopathology.
Renga et al. 2020Life science alliancecited by 26
PMID 32817121PMC7441522DOI 10.26508/lsa.202000662PUB-32817121
Trial · Interventional
Active, not recruitingPhase 2Registry dataChina
1 trial · 1 ongoing
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
NCT060568043 Jan 2024 to est. 1 Jul 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.
Experimental
cCRT+tislelizumab+thymalfasin
A total of 20 pMMR/MSS locally advanced middle and low rectal cancer patients will receive long-course concurrent chemoradiotherapy combined with 3 cycles of tislelizumab and 11 weeks of thymalfasin therapy.
Outcomes the sponsor listed as primary.
CR rate
Time frame · from preoperative to 10 days postoperative
complete response rate, If patients achieved cCR after neoadjuvant therapy or were confirmed pCR after TME, they were considered as complete response (CR). pCR was defined as no residual tumor cells on the histologic examination of surgical specimens according to AJCC 8th edition. cCR was defined according to the Memorial Sloan Kettering Cancer Center (MSKCC) standard.
TRAE
Time frame · from commencing of treatment to the 30th day after surgery
incidence of treatment-related adverse event
30-day incidence of postoperative complications
Time frame · within 30 days after surgery
incidence of surgical complications within 30 days after surgery
ORR
Time frame · before surgery
objective response rate; The ORR rate is the result of complete response (CR) rate plus partial response (PR) rate.
3-y DFS rate
Time frame · 3 years
3-year disease free survival rate
NAR score
Time frame · within 10 days after surgery
neoadjuvant rectal score
R0 resection rate
Time frame · within 10 days after surgery
rate of R0 resection
anal preservation rate
Time frame · instantly after surgery
proportion of patients with preserved anal sphincter
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
Indexing hint: Animal study · 2020
Renga et al. 2020Life science alliancecited by 26
PMID 32817121PMC7441522DOI 10.26508/lsa.202000662PUB-32817121
PubMed tag: none · 2018
Danielli et al. 2018Expert opinion on biological therapycited by 20
PMID 30063847DOI 10.1080/14712598.2018.1494717PUB-30063847
Indexing hint: Animal study · 2015
King et al. 2015Expert opinion on biological therapycited by 18
PMID 25643200DOI 10.1517/14712598.2015.1008446PUB-25643200
Who could join, as posted.
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