Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 12:27 PM
Study NCT ID:
NCT06056804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2023-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'neoadjuvant chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The expression of CD68', 'timeFrame': 'up to 3 months after surgery', 'description': 'The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC'}, {'measure': 'The expression of CD86', 'timeFrame': 'up to 3 months after surgery', 'description': 'The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC'}, {'measure': 'The expression of CD163', 'timeFrame': 'up to 3 months after surgery', 'description': 'The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC'}, {'measure': 'The expression of CD4', 'timeFrame': 'up to 3 months after surgery', 'description': 'The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC'}, {'measure': 'The expression of CD8', 'timeFrame': 'up to 3 months after surgery', 'description': 'The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC'}], 'primaryOutcomes': [{'measure': 'CR rate', 'timeFrame': 'from preoperative to 10 days postoperative', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'TRAE', 'timeFrame': 'from commencing of treatment to the 30th day after surgery', 'description': 'incidence of treatment-related adverse event'}, {'measure': '30-day incidence of postoperative complications', 'timeFrame': 'within 30 days after surgery', 'description': 'incidence of surgical complications within 30 days after surgery'}, {'measure': 'ORR', 'timeFrame': 'before surgery', 'description': 'objective response rate; The ORR rate is the result of complete response (CR) rate plus partial response (PR) rate.'}, {'measure': '3-y DFS rate', 'timeFrame': '3 years', 'description': '3-year disease free survival rate'}, {'measure': 'NAR score', 'timeFrame': 'within 10 days after surgery', 'description': 'neoadjuvant rectal score'}, {'measure': 'R0 resection rate', 'timeFrame': 'within 10 days after surgery', 'description': 'rate of R0 resection'}, {'measure': 'anal preservation rate', 'timeFrame': 'instantly after surgery', 'description': 'proportion of patients with preserved anal sphincter'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pMMR/MSS', 'locally Advanced Rectal Cancer', 'PD-1', 'neoadjuvant', 'chemoradiation', 'Thymalfasin'], 'conditions': ['Locally Advanced Rectal Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Amin, M. B. et al. AJCC cancer staging manual. (New York: Springer. 252-274 2017)'}, {'pmid': '33264544', 'type': 'BACKGROUND', 'citation': 'Andre T, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fouchardiere C, Rivera F, Elez E, Bendell J, Le DT, Yoshino T, Van Cutsem E, Yang P, Farooqui MZH, Marinello P, Diaz LA Jr; KEYNOTE-177 Investigators. Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer. N Engl J Med. 2020 Dec 3;383(23):2207-2218. doi: 10.1056/NEJMoa2017699.'}, {'pmid': '25643200', 'type': 'BACKGROUND', 'citation': 'King RS, Tuthill C. Evaluation of thymosin alpha 1 in nonclinical models of the immune-suppressing indications melanoma and sepsis. Expert Opin Biol Ther. 2015;15 Suppl 1:S41-9. doi: 10.1517/14712598.2015.1008446. Epub 2015 Feb 2.'}, {'pmid': '30063847', 'type': 'BACKGROUND', 'citation': 'Danielli R, Cisternino F, Giannarelli D, Calabro L, Camerini R, Savelli V, Bova G, Dragonetti R, Di Giacomo AM, Altomonte M, Maio M. Long-term follow up of metastatic melanoma patients treated with Thymosin alpha-1: investigating immune checkpoints synergy. Expert Opin Biol Ther. 2018 Jul;18(sup1):77-83. doi: 10.1080/14712598.2018.1494717.'}, {'pmid': '32817121', 'type': 'BACKGROUND', 'citation': "Renga G, Bellet MM, Pariano M, Gargaro M, Stincardini C, D'Onofrio F, Mosci P, Brancorsini S, Bartoli A, Goldstein AL, Garaci E, Romani L, Costantini C. Thymosin alpha1 protects from CTLA-4 intestinal immunopathology. Life Sci Alliance. 2020 Aug 14;3(10):e202000662. doi: 10.26508/lsa.202000662. Print 2020 Oct."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study is an open, prospective, multi-center, single-arm phase II clinical study. In this study, patients with pMMR/MSS locally advanced middle and low rectal cancer were selected as the subjects and treated with neoadjuvant treatment protocol of long-course concurrent chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin. The primary endpoint of the study was complete response (CR) rate. The secondary end points included treatment-related adverse events (TRAEs) rate, 30-day incidence of postoperative complications, objective response rate (ORR), 3-year disease-free survival (DFS) rate, Neoadjuvant rectal cancer (NAR) score, R0 resection rate, and anal preservation rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients who were fully informed of the study and voluntarily signed the informed consent form;\n2. Patients with rectal cancers must satisfied all the following conditions:\n\n1\\) Stage II/III LARC (cT3-4aN0M0 and cT1-4aN1-2M0); 2) Tumor distal located ≤ 10 cm from anal verge (MRI diagnosed); 3) pMMR or MSS confirmed by immunohistochemistry or genetic test. 3.Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1; 4. Physical and viscera function of patients can withstand major abdominal surgery; 5.Patients are willing and able to follow the study protocol during the study 6.Patients give consent to the use of pathological specimens for study 7.Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.\n\nExclusion Criteria:\n\n1. Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;\n2. Patients underwent major surgery within 4 weeks prior to study treatment;\n3. Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;\n4. Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;\n5. Patients who are allergic to any of the ingredients under study;\n6. Patients with severe concomitant diseases with estimated survival ≤ 5 years;\n7. Patients with present or previous moderate or severe liver and kidney damage presently or previously;\n8. Patients have received other study medications or any immunotherapy currently or in the past;\n9. Patients preparing for or previously received organ or bone marrow transplant;\n10. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;\n11. Patients with congenital or acquired immune deficiency (such as HIV infection);\n12. If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;\n13. Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.\n14. Pregnant or lactating women\n\nCriteria for Withdrawal:\n\n1. The subject withdraws informed consent;\n2. The subject requests to withdraw from the study, or loses follow-up;\n3. The subject demonstrates poor compliance and is unable to participate in the treatment and visits as required by the study protocol;\n4. The subject experiences intolerable adverse events, and the investigator determines that continuing the study may be detrimental to the subject;\n5. Other reasons, where the investigator determines it is not suitable for the subject to continue in the study.\n\nCriteria for Study Termination:\n\n1. There are major errors in the study protocol;\n2. The study involves significant risks and is terminated following review by the ethics committee;\n3. Termination requested by the sponsor or regulatory authorities."}, 'identificationModule': {'nctId': 'NCT06056804', 'briefTitle': 'Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study', 'orgStudyIdInfo': {'id': 'ZDX+PD-1-LARC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cCRT+tislelizumab+thymalfasin', 'description': '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.', 'interventionNames': ['Drug: capecitabine', 'Drug: tislelizumab', 'Drug: thymalfasin', 'Radiation: long-term radiotherapy']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': '825-1000mg/m2,po,bid', 'armGroupLabels': ['cCRT+tislelizumab+thymalfasin']}, {'name': 'tislelizumab', 'type': 'DRUG', 'description': '200mg,iv.gtt,q3w', 'armGroupLabels': ['cCRT+tislelizumab+thymalfasin']}, {'name': 'thymalfasin', 'type': 'DRUG', 'description': '4.8mg,sc,biw', 'armGroupLabels': ['cCRT+tislelizumab+thymalfasin']}, {'name': 'long-term radiotherapy', 'type': 'RADIATION', 'description': '50 Gy/25 f, 2 Gy/day', 'armGroupLabels': ['cCRT+tislelizumab+thymalfasin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Friendship Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Export of individual patient data is a sensitive issue according to current Chinese laws.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zhongtao Zhang', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}