Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT06853769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-03
First Post:
2024-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720860', 'term': 'penpulimab'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic complete response rate（pCR）', 'timeFrame': 'assessment 2-4 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': 'assessment 2-4 weeks after surgery'}, {'measure': 'Disease-free survival at 3 years', 'timeFrame': 'from enrollment to three years after surgery'}, {'measure': 'OS at 3 years', 'timeFrame': 'from enrollment to three years later'}, {'measure': 'RECIST1.1 Objective response rate as assessed', 'timeFrame': '1-2 weeks before surgery'}, {'measure': 'RECIST1.1 Disease control rate evaluated', 'timeFrame': '1-2 weeks before surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical efficacy and safety of anlotinib in combination with penpulimab and conventional chemoradiotherapy for the neoadjuvant treatment of locally advanced rectal cancer', 'detailedDescription': 'Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14 Radiation therapy 1.8-2Gy/50-55Gy\n\nChemotherapy:\n\nCapecitabine 800mg/m2 P.O. BID D1-D14, or capecitabine plus oxaliplatin 130mg/m2. Every 21 days is 1 cycle In the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; After the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n-Patient's age: 18 years old - 80 years old -\n\n* Rectal cancer patients diagnosed with adenocarcinoma by pathological examination of primary biopsy\n* Patients with no prior treatment, preoperative clinical stage: cT3-4N+M0 rectal cancer patients (AJCC 8th);\n* Patients who agree to undergo radical surgical treatment and have no contraindications to surgery as judged by the surgeon;\n* No other multiple primary cancers;\n* At least 1 measurable or evaluable lesion according to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST v1.1);\n* Expected survival time≥ 3 months;\n* A score of 0-1 based on the United States Eastern Cooperative Oncology Group Performance Status Score (ECOG PS score);\n* The investigator plans to give PD-1 monoclonal antibody combined with chemotherapy treatment regimen after evaluation, and signs informed consent.\n\nExclusion Criteria:\n\n* Active, known or suspected autoimmune disease;\n* Known history of primary immunodeficiency;\n* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n* Pregnant or lactating female patients;\n* Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;\n* Uncontrolled intercurrent illness including but not limited to:\n* People living with HIV (HIV antibody positive)\n* Severe infections that are active or poorly clinically controlled\n* Patients with active hepatitis\n* Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological, epilepsy or dementia, unstable or incompensable respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \\[i.e., greater than or equal to CTCAE grade 2 hypertension despite medication\\]).\n* Patients with active bleeding or new thrombotic disease, taking therapeutic dose of anticoagulant drugs or bleeding tendency, abnormal coagulation function (INR\\>1.5×ULN, APTT\\>1.5×ULN);\n* Those who are currently undergoing clinical trials of other drugs;\n* Other patients who are considered by the investigator to be unsuitable for inclusion."}, 'identificationModule': {'nctId': 'NCT06853769', 'acronym': 'LARC-nCR01', 'briefTitle': 'Neoadjuvant Therapy for Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Prospective, Single-arm, Single-center Exploratory Clinical Study of Anlotinib in Combination With Penpulimab and Conventional Chemoradiotherapy for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer', 'orgStudyIdInfo': {'id': '2024-SR-563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14 Radiation therapy 1.8-2Gy/50-55Gy\n\nChemotherapy:\n\nCapecitabine 800mg/m2 P.O. BID D1-D14, or capecitabine plus oxaliplatin 130mg/m2. Every 21 days is 1 cycle In the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; After the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.', 'interventionNames': ['Drug: Anlotinib hydrochloride,Penpulimab']}], 'interventions': [{'name': 'Anlotinib hydrochloride,Penpulimab', 'type': 'DRUG', 'otherNames': ['FOCUS'], 'description': 'Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': "Jiangsu Provincial People's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}