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L'essai clinique NCT07162714 (STAR) pour Cancer rectal, Radiation, AK112 est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer (STAR)

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT07162714 (STAR) est conçu pour étudier le treatment de Cancer rectal, Radiation, AK112. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 septembre 2025, avec un objectif de 30 participants. Dirigé par Zhejiang Cancer Hospital, l'essai devrait être terminé d'ici le 31 décembre 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 septembre 2025.
Résumé succinct
Primary Objectives： Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR/MSS mid - low rectal cancer.

Secondary Objectives： Evaluate treatment - related toxic reactions, the quality of life, long - term prognosis (local control [LC], disease - free survival [DFS] and overall survival [OS]).

Patients will :

Receive Radiotherapy: Pelvic IMRT or VMAT, DT 25Gy/5Fx. One week after radiotherapy, begin treatment with Ivorsimab (AK112) at a dose of 20mg/kg by intravenous drip on day 1. One cycle is 21 days, and a total of 6 cycles are to be carried out.

Evaluate the curative effect after 3 cycles of treatment. Patients with progressive disease (PD) will withdraw from the study, and other treatment plans will be adjusted in a timely manner. Patients with CR/PR/SD will continue treatment for another 3 cycles. Conduct a comprehensive assessment after 6 cycles of treatment. Patients who achieve cCR can choose the watch - and - wait approach. For patients who do not achieve cCR, TME surgery is recommended. Decide whether to perform adjuvant chemotherapy based on the postoperative pathological findings.

Titre officiel

Short-Course Radiotherapy Followed by Ivonescimab (AK112) in pMMR/MSS Mid-Low Rectal Cancer: An Exploratory Phase II Clinical Study.

Conditions
Cancer rectalRadiationAK112
Autres identifiants de l'essai
  • STAR
Numéro NCT
NCT07162714
Date de début (réel)
2025-09-01
Dernière mise à jour publiée
2025-09-09
Date de fin (estimée)
2028-12-31
Inscription (estimée)
30
Type d'essai
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalExperimental arm
The patients receive pelvic radiotherapy: Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT), with a total dose of 25 Gy delivered in 5 fractions. One week post-radiotherapy, treatment with Ivonescimab (AK112) was initiated at a dose of 20 mg/kg via intravenous infusion on Day 1 of each 21-day cycle, for a total of 6 cycles. Treatment response was assessed after 3 cycles. Patients with Progressive Disease (PD) were withdrawn from the study and promptly switched to alternative regimens. Patients achieving CR/PR/SD continued treatment for an additional 3 cycles.A comprehensive evaluation was conducted after completing 6 cycles. Patients achieving clinical Complete Response (cCR) were eligible for watchful waiting. For those not attaining cCR, Total Mesorectal Excision (TME) surgery was recommended. The need for adjuvant chemotherapy was subsequently determined based on postoperative pathological findings.
Radiothérapie
The patients receive pelvic radiotherapy: Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT), with a total dose of 25 Gy delivered in 5 fractions. Radiotherapy is to start on day 1 and to finish on day 5.
Ivonescimab (20mg/KG Q3W)
The first dose of vonescimab (AK112) was administered 1 week after the completion of radiotherapy. Ivonescimab (AK112) was initiated at a dose of 20 mg/kg via intravenous infusion on Day 1 of each 21-day cycle, for a total of 6 cycles.
Non-operative Management
Subjects who achieve cCR after radiation and 6 cycles treatment of Ivonescimab can, after discussion with the local investigator, decline surgery and opt for a non-operative management.
Chirurgie
For patients who do not achieve cCR at the end of 6 cycles treatment of Ivonescimab, TME surgery is recommended.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Complete remission rate (CR rate)
including clinical complete response rate (cCR) and pathological complete response rate (pCR). pCR status is defined as the absence of resected speci mens with surviving tumour cells. cCR is defined as undetectable signs of tumour at least 4 weeks after TNT completion by clinical ex amination, including magnetic resonance imaging (MRI), endoscopy, digital rectal examination (DRE) and Positron Emission Tomography-Computed Tomography (PET-CT).
at the end of 6 cycles of AK112 treatment (each cycle is 21 days) or after surgery
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Treatment - related adverse reactions
Number of Participants with Treatment - related adverse reactions according to CTCAE 5.0
From enrollment to 6 months after the last administration of study treatment
locoregional control rate
from the date of registration to the date of occurrence of locoregional recurrence, or death due to any cause.
Up to 3 years after the last administration of study treatment
disease-free survival rate
from the date of registration to the date of occurrence of any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
Up to 3 years after the last administration of study treatment
Overall survival rate
from the date of registration to the date of death from any cause.
Up to 3 years after the last administration of study treatment
Qol EORTC-C30 questionnaire
From enrollment to 6 months after the last administration of study treatment
Qol EORTCQLQ- CR29 questionnaire
From enrollment to 6 months after the last administration of study treatment
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  1. Aged between 18 and 75 years old;
  2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1;
  3. Histopathologically confirmed rectal adenocarcinoma, without any prior anti - tumor treatment; The status of MMR/MSI is detected by IHC/PCR in pathological biopsy to clarify that the patient's classification is pMMR/MSS;
  4. The lower border of the lesion is ≤ 7 cm from the anal verge as determined by fibrocolonoscopy or digital rectal examination;
  5. Baseline magnetic resonance staging is cT2 - 4 and/or N+, excluding any of cT4b, N2, positive mesorectal fascia (MRF+), extramural venous invasion (EMVI+), lateral lymph node metastasis, and distant metastasis (according to the 8th edition of the AJCC Cancer Staging Manual);
  6. Able to accept the treatment plan during the study period;
  7. Signed written informed consent.

  1. Uncontrolled epilepsy, history of central nervous system disorders or psychiatric conditions that, in the investigator's judgment, may interfere with the ability to provide informed consent or affect compliance with oral medication.
  2. Prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies.
  3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, congestive heart failure (New York Heart Association [NYHA] Class II or higher), severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.
  4. Immunosuppressive therapy following organ transplantation.
  5. History of other malignancies within the past 5 years (excluding adequately treated non-melanoma skin cancer or carcinoma in situ).
  6. Severe uncontrolled recurrent infections or other significant uncontrolled comorbidities.
  7. Baseline laboratory values failing to meet the following criteria:Hemoglobin ≥80 g/L; Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100×10^9/L; ALT/AST ≤2.5×upper limit of normal (ULN); Alkaline phosphatase (ALP) ≤2.5×ULN; Total bilirubin <1.5×ULN; Serum creatinine <1×ULN
  8. Active gastrointestinal diseases (e.g., gastric/duodenal ulcers, ulcerative colitis), unresected tumors with active bleeding, or other conditions deemed by the investigator to pose risks of gastrointestinal bleeding or perforation.
  9. Active bleeding or bleeding predisposition.
  10. Pregnancy or lactation.
  11. Hypersensitivity to any component of the investigational drug(s).
Zhejiang Cancer Hospital logoZhejiang Cancer Hospital
Partie responsable de l'essai
Ji Zhu, Investigateur principal, Professor, Zhejiang Cancer Hospital
Aucune donnée de contact disponible