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Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer

ConditionAdvanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18-75 years old;

rectal adenocarcinoma confirmed by histology and/or cytology;

locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017);

Distance from lower margin to anal margin ≤ 10 cm;

Disqualifiers

patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 5 years;

patients with mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H);

obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/ day or clopidogrel ≥75 mg/ day) may be required.

extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases);

Trial design

Design model

Single group

Treatments tested in this trial

  • Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy

    Drug

    Phase One: Induction immunotherapy Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for two treatment cycles Phase Two: Short-course radiotherapy Short-course radiotherapy: 5x5Gy, once a day, 5Gy each time, for 5 consecutive days. After radiotherapy, rest for 7 to 14 days before starting consolidation immunotherapy. After radiotherapy, conduct imaging evaluations of tumor remission. Phase Three: Consolidation of chemotherapy-free treatment Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles Phase Four: W\&W

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined with Short-Course RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete response plus pathological complete response

Through imaging examinations such as CT, MRI or PET-CT, it was confirmed that all visible tumor lesions had completely disappeared and remained there for at least 4 weeks. After surgical resection of the tumor tissue, no residual cancer cells (including the primary lesion and lymph nodes) were found under microscopic examination.

Time frame
1 year

Secondary outcomes

1

Progression-free survival

The time from randomization to disease progression or death

Time frame
2 year
2

OS

The period from the time a patient randomly receives treatment until death due to any cause.

Time frame
3 year
3

Adverse Event

All adverse medical events that occurred after the subjects accepted the trial protocol.

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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