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Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC

ConditionEfficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHebei Medical University Fourth Hospital

About this trial

Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.age >=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR .

Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L.

Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)

Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.

Disqualifiers

Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma.

Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer.

Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment.

Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental: short-course radiotherapy and immunotherapy

    Drug

    patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and Enlonstobart Enlonstobart 200mg IV every 3 weeks; Oxaliplatin 130mg/m2 IV Q3W d1 Capecitabine 1000mg/m2 bid d1-14 q3w

  • Chemoradiotherapy

    Drug

    Long-course radiotherapy +Capecitabine 825mg/m2 bid d1-d14, followed by 4 cycles of CAPOX chemotherapy

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: short-course radiotherapy and immunotherapyExperimental treatment 1 intervention
Group B: chemoradiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complete response Rate (pCR+cCR )

Clinical complete response or pathological complete response (cCR or pCR)

Time frame
up to 2 year

Secondary outcomes

1

Major pathologic response rate

Time frame
up to 2 year
2

R0 resection rate

Time frame
The R0 resection rate will be evaluated after surgery, an average of 4 weeks
3

3-year event-free survival (EFS) rate

Time frame
up to 3 years
4

3-year overall survival (OS)

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov
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