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OpenTrials
Active, Not Recruiting

NCT Number: NCT06215677

Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-75 years;
  • ECOG score 0-2;
  • Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
  • Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
  • Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;
  • No evidence of distant metastasis;
  • Newly treated patients who have not received treatment including chemotherapy and surgery;
  • Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;
  • Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.

Exclusion criteria

  • A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
  • Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
  • Patients with a history of severe mental illness, immune disease, hormone medication;
  • Patients contraindicated by immunotherapy or surgery;
  • Participated in other clinical researchers in the past 3 months;
  • Any other circumstances that the investigator considers inappropriate for inclusion.

Treatment and study plan

Camrelizumab

Drug

Camrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon.

Primary outcomes

  1. the rate of R0 resection

    Time frame: Tumour specimen evaluated within 2 weeks after surgery

    No tumor infiltration within 1 mm of the surgical margins

Secondary outcomes

  1. Pathological complete response (pCR)

    Time frame: Tumour specimen evaluated within 2 weeks after surgery.

    Number of patients with pCR evaluated according to the Mandard tumour regression grading system

  2. diesease-free survival

    Time frame: 3 years

    No tumor regrowth or recurrence or metastasis found

  3. overall survival

    Time frame: 5 years

    Refers to the proportion of patients still alive at 5 years after surgery

  4. Safety and tolerability of Camrelizumab administered

    Time frame: Up to approximately 9 weeks

    Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial

Acronym: NITDC

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Jan 22, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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