Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
Sintilimab Combined With Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy vs. Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy for Total Neoadjuvant Therapy in Patients With Mismatch Repair-Proficient (pMMR) or Microsatellite Stable/Low Microsatellite Instability (MSS/MSI-L) Locally Advanced Rectal Cancer: A Multicenter, Randomized, Double-Blind, Controlled Phase III Study
This is a randomized, double-blind, controlled, Phase III clinical study to evaluate the efficacy and safety of sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy, which is planned to enroll 500 subjects with locally advanced rectal cancer.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Yanxi Pu
- Telefonní číslo: +86-18523197816
- E-mail: yanxi.pu@innoventbio.com
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510060
- Sun Yat sen University Cancer Center
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Kontakt:
- Ruihua Xu
- Telefonní číslo: +86-20-87343468
- E-mail: xurh2@sysucc.org.cn
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria
- Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
- Histopathologically confirmed locally advanced rectal adenocarcinoma, with clinical stage cT3-4NanyM0 or cT1-2N1-2M0 as defined by the AJCC 8th edition, and assessed as amenable to R0 resection after neoadjuvant therapy. MRI demonstrates that the lower edge of the tumor is within 10 cm from the anal verge.
- Tumor pathological tissue testing confirms pMMR, i.e., immunohistochemical staining shows positive expression of all four proteins MLH1, MSH2, MSH6, and PMS2, or tumor tissue-based genetic testing indicates MSI-L or MSS.
- No signs of intestinal obstruction; or intestinal obstruction that has been relieved after proximal colostomy.
- No prior rectal surgery; no prior systemic anti-cancer therapy, or other investigational drug therapy.
- Age ≥18 years, both sexes eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Expected survival of ≥2 years.
- Adequate bone marrow and organ function. Exclusion Criteria
1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
2. Plans to receive other anti-tumor therapy during the treatment period of this study.
3. Receipt of any live vaccine within 4 weeks before the first dose of study drug, or plans to receive any live vaccine during the study period.
4. Presence of toxicity from prior therapy that has not recovered to Grade 0 or 1 per NCI CTCAE V6.0 before the first dose of study drug (excluding alopecia, fatigue, pigmentation, and other conditions judged by the investigator to pose no safety risk).
5. Major surgery 6. Receipt of immunosuppressive therapy within 4 weeks before the first dose of study drug, excluding topical corticosteroids administered intranasally, by inhalation, or by other local routes, or physiological doses of systemic corticosteroids , or corticosteroids used to prevent contrast agent allergy.
7. Recurrent rectal cancer; multiple primary colorectal cancers. 8. History of pelvic or abdominal radiotherapy.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo
Placebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
130 mg/m²，IV，Q3W 20 ml D1 IV Q3W PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) 825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； Radical resection of rectal cancer |
|
Experimentální: Sintilimab
sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
130 mg/m²，IV，Q3W PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) 825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； Radical resection of rectal cancer 200 mg D1 IV Q3W |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
EFS
Časové okno: throutg treatment completion an average of 5 years
|
EFS refers to the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, death from any cause, etc. |
throutg treatment completion an average of 5 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
OS
Časové okno: throutg treatment completion an average of 5 years
|
OS is defined as the time from the date of randomization until the date of death from any cause. |
throutg treatment completion an average of 5 years
|
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CCR
Časové okno: up to 5 years after enrollment
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CCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR) |
up to 5 years after enrollment
|
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R0 resection rate
Časové okno: up to 5 years after enrollment
|
R0 resection rate: Descriptive summary of R0 resection rate |
up to 5 years after enrollment
|
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EFS3
Časové okno: 3yaers
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EFS3 defined as the proportion of participants who remain free from any of the following events for 3 years after randomization: disease progression precluding surgery, local or distant recurrence, or death from any cause |
3yaers
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TRG
Časové okno: up to 5 years after enrollment
|
Pathological assessment of tumor regression grading (TRG) after neoadjuvant therapy |
up to 5 years after enrollment
|
|
neoadjuvant therapy completion rate
Časové okno: up to 5 years after enrollment
|
Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate |
up to 5 years after enrollment
|
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OPR
Časové okno: up to 5 years after enrollment
|
The definition of organ preservation is: no radical total mesorectal excision (TME) performed, and no local regrowth, unless such regrowth can be salvaged by local excision achieving a limited, radical (R0) resection, with no permanent stoma (including a protective stoma that has never been reversed, or a stoma resulting from adverse events and/or poor functional outcome, or a permanent stoma). |
up to 5 years after enrollment
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Terapeutika
- Nukleové kyseliny, nukleotidy a nukleosidy
- Koordinační komplexy
- Deoxycytidin
- Cytidin
- Pyrimidinové nukleosidy
- Pyrimidiny
- Nukleosidy
- Uracil
- Pyrimidinony
- Deoxyribonukleosidy
- Fluorouracil
- Kapecitabin
- Oxaliplatina
- Radioterapie
- Sintilimab
Další identifikační čísla studie
- CIBI308H301
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