Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University Cancer Hospital & Institute

About this trial

This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR ($\\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR). Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Retrospective Cohort Inclusion Criteria

Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.

Completed prior immunotherapy.

No evidence of distant metastasis.

Disqualifiers

Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.

Serum creatinine > 1.5 times upper limit of normal (ULN).

History of pelvic radiation therapy.Inability to tolerate MRI examinations.

History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).

Trial population

Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NOM

    Other intervention

    Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch \& Wait" (W\&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0) may undergo local excision (LE) or endoscopic resection (ESD/EMR).

  • RO

    Other intervention

    Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental Cohort (NOM)1 intervention
Group B: Control arm1 intervention

Trial outcomes

Primary outcomes

1

Organ Preservation Rate

The proportion of patients successfully managed with NOM without the need for supplementary radical surgery, loss of organ function, or a permanent stoma (specifically for rectal cancer patients).

Time frame
3 years after the completion of neoadjuvant immunotherapy.

Secondary outcomes

1

Surgical Safety and Postoperative Complications

Incidence and severity of perioperative complications classified by the Clavien-Dindo grading system, comparing RO, LE, and endoscopic resection (ESD/EMR).

Time frame
3 years after the completion of neoadjuvant immunotherapy.
2

Distribution of Pathological Response (RO Group Only)

Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy.

Time frame
At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
3

Local Regrowth Rate

The proportion of patients experiencing local tumor regrowth in the W\&W group or after local/endoscopic excision.

Time frame
Regular follow-up every 3-6 months for up to 3 years.
4

Overall Survival (OS)

Time from the start of treatment to death from any cause.

Time frame
Up to 5 years.

Other outcomes

Sponsors and contacts

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