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Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer

30. oktober 2026 opdateret af: Innovent Biologics (Suzhou) Co. Ltd.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Sun Yat sen University Cancer Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  1. Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
  2. 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.
  3. 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.
  4. No signs of intestinal obstruction; or intestinal obstruction that has been relieved after proximal colostomy.
  5. No prior rectal surgery; no prior systemic anti-cancer therapy, or other investigational drug therapy.
  6. Age ≥18 years, both sexes eligible.
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  8. Expected survival of ≥2 years.
  9. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo

Placebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy
Medicin: Oxaliplatin

130 mg/m²，IV，Q3W

Medicin: Placebo

20 ml D1 IV Q3W

Stråling: radiotherapy

PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35)

Medicin: Capecitabine

825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W；

Procedure: Radical resection of rectal cancer

Radical resection of rectal cancer
Eksperimentel: Sintilimab

sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy
Medicin: Oxaliplatin

130 mg/m²，IV，Q3W

Stråling: radiotherapy

PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35)

Medicin: Capecitabine

825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W；

Procedure: Radical resection of rectal cancer

Radical resection of rectal cancer

Medicin: Sintilimab

200 mg D1 IV Q3W

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EFS
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
OS
Tidsramme: 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
CCR
Tidsramme: up to 5 years after enrollment

CCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR)
up to 5 years after enrollment
R0 resection rate
Tidsramme: up to 5 years after enrollment

R0 resection rate: Descriptive summary of R0 resection rate
up to 5 years after enrollment
EFS3
Tidsramme: 3yaers

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
TRG
Tidsramme: 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
Tidsramme: up to 5 years after enrollment

Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate
up to 5 years after enrollment
OPR
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. november 2026

Primær færdiggørelse (Anslået)

25. marts 2030

Studieafslutning (Anslået)

24. november 2031

Datoer for studieregistrering

Først indsendt

19. oktober 2026

Først indsendt, der opfyldte QC-kriterier

30. oktober 2026

Først opslået (Faktiske)

4. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIBI308H301

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